Text · Amendment list
On the proposal for a regulation of the European Parliament and of the Council Amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements
Full title
On the proposal for a regulation of the European Parliament and of the Council Amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements
Document CJ14-AM-791052 · COM(2025)1030 – C100359/2025 – 2025/0410(COD)
- Kind
- Amendment list CJ14-AM-791052
- Date
- 28 July 2026
- Committee
- Committee on the Environment, Climate and Food Safety Committee on Agriculture and Rural Development
- Dossier
- 2025-0410
More facts (2)
- Formats
- Official page PDF Word
- Reference
- COM(2025)1030 – C100359/2025 – 2025/0410(COD)
Text
The text as parsed from the official Word file. Every paragraph has a link (¶) and can be saved to a project as a passage.
Jump to an amendment (152)
- Amendment 1337
- Amendment 1338
- Amendment 1339
- Amendment 1340
- Amendment 1341
- Amendment 1342
- Amendment 1343
- Amendment 1344
- Amendment 1345
- Amendment 1346
- Amendment 1347
- Amendment 1348
- Amendment 1349
- Amendment 1350
- Amendment 1351
- Amendment 1352
- Amendment 1353
- Amendment 1354
- Amendment 1355
- Amendment 1356
- Amendment 1357
- Amendment 1358
- Amendment 1359
- Amendment 1360
- Amendment 1361
- Amendment 1362
- Amendment 1363
- Amendment 1364
- Amendment 1365
- Amendment 1366
- Amendment 1367
- Amendment 1368
- Amendment 1369
- Amendment 1370
- Amendment 1371
- Amendment 1372
- Amendment 1373
- Amendment 1374
- Amendment 1375
- Amendment 1376
- Amendment 1377
- Amendment 1378
- Amendment 1379
- Amendment 1380
- Amendment 1381
- Amendment 1382
- Amendment 1383
- Amendment 1384
- Amendment 1385
- Amendment 1386
- Amendment 1387
- Amendment 1388
- Amendment 1389
- Amendment 1390
- Amendment 1391
- Amendment 1392
- Amendment 1393
- Amendment 1394
- Amendment 1395
- Amendment 1396
- Amendment 1397
- Amendment 1398
- Amendment 1399
- Amendment 1400
- Amendment 1401
- Amendment 1402
- Amendment 1403
- Amendment 1404
- Amendment 1405
- Amendment 1406
- Amendment 1407
- Amendment 1408
- Amendment 1409
- Amendment 1410
- Amendment 1411
- Amendment 1412
- Amendment 1413
- Amendment 1414
- Amendment 1415
- Amendment 1416
- Amendment 1417
- Amendment 1418
- Amendment 1419
- Amendment 1420
- Amendment 1421
- Amendment 1422
- Amendment 1423
- Amendment 1424
- Amendment 1425
- Amendment 1426
- Amendment 1427
- Amendment 1428
- Amendment 1429
- Amendment 1430
- Amendment 1431
- Amendment 1432
- Amendment 1433
- Amendment 1434
- Amendment 1435
- Amendment 1436
- Amendment 1437
- Amendment 1438
- Amendment 1439
- Amendment 1440
- Amendment 1441
- Amendment 1442
- Amendment 1443
- Amendment 1444
- Amendment 1445
- Amendment 1446
- Amendment 1447
- Amendment 1448
- Amendment 1449
- Amendment 1450
- Amendment 1451
- Amendment 1452
- Amendment 1453
- Amendment 1454
- Amendment 1455
- Amendment 1456
- Amendment 1457
- Amendment 1458
- Amendment 1459
- Amendment 1460
- Amendment 1461
- Amendment 1462
- Amendment 1463
- Amendment 1464
- Amendment 1465
- Amendment 1466
- Amendment 1467
- Amendment 1468
- Amendment 1469
- Amendment 1470
- Amendment 1471
- Amendment 1472
- Amendment 1473
- Amendment 1474
- Amendment 1475
- Amendment 1476
- Amendment 1477
- Amendment 1478
- Amendment 1479
- Amendment 1480
- Amendment 1481
- Amendment 1482
- Amendment 1483
- Amendment 1484
- Amendment 1485
- Amendment 1486
- Amendment 1487
- Amendment 1488
| Text proposed by the Commission | Amendment |
|---|---|
| (2) in Article 4, paragraph 3, point (h) is replaced by the following: | deleted |
| ‘(h) the date of approval and, when appropriate, the expiry date of the approval of the active substance.;’ |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| (2a) In Article 5, the introductory part of paragraph 1 is replaced by the following: | |
| "In accordance with the precautionary principle and subject to paragraph 2, the following active substances shall be approved:" |
| Present text | Amendment |
|---|---|
| (2a) in Article 5, paragraph 2, point c is replaced by the following: | |
| (c) not approving the active substance would have a dispropor tionate negative impact on society when compared with the risk to human health, animal health or the environment arising from the use of the substance. When deciding whether an active substance may be approved in accordance with the first subparagraph, the availability of suitable and sufficient alternative substances or technologies shall be a key consideration. The use of a biocidal product containing active substances approved in accordance with this paragraph shall be subject to appropriate risk-mitigation measures to ensure that exposure of humans, animals and the environment to those active substances is minimised. The use of the biocidal product with the active substances concerned shall be restricted to Member States in which at least one of the conditions set out in this paragraph is met. | "(c) not approving the active substance would have a dispropor tionate negative impact on society or climate when compared with the risk to human health, animal health or the environment arising from the use of the substance. When deciding whether an active substance may be approved in accordance with the first subparagraph, the availability of suitable and sufficient alternative substances or technologies shall be a key consideration. The use of a biocidal product containing active substances approved in accordance with this paragraph shall be subject to appropriate risk-mitigation measures to ensure that exposure of humans, animals and the environment to those active substances is minimised. The use of the biocidal product with the active substances concerned shall be restricted to Member States in which at least one of the conditions set out in this paragraph is met." |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| (2b) In Article 5, the introductory part of paragraph 2 is replaced by the following: | |
| "Without prejudice to Article 4(1), active substances referred to in paragraph 1 of this Article shall be approved if it is shown that at least one of the following conditions is met:" |
| Present text | Amendment |
|---|---|
| (2b) In Article 6, paragraph 2, a new point ca is added: | |
| "(ca) The data requirement came into effect more than 365 days after the submission of the application. Article 88 applies without prejudice." |
| Text proposed by the Commission | Amendment |
|---|---|
| (2a) In Article 6, paragraph 2 the following new point ca is added: | |
| "(ca) The data requirement came into effect more than 365 days after the submission of the application. Article 88 applies without prejudice.” |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Present text | Amendment |
|---|---|
| (2a) in Article 6, paragraph 2, a new point ca is added | |
| "(ca) The data requirement came into effect more than 365 days after the submission of the application. Article 88 applies without prejudice. |
The data requirements should not be changed while an application procedure is still pending. The evaluating competent authorities are in charge to raise the different requirements and any specific concern during the drafting of the assessment report. New requirements should not be asked during the risk management phase nor at the ECHA stage.
| Text proposed by the Commission | Amendment |
|---|---|
| (3) in Article 9, paragraph (1), point (a) is replaced by the following: | deleted |
| ‘(a) adopt an implementing Regulation providing that an active substance is approved, and under which conditions, including the date of approval and, when appropriate, date of expiry of the approval; or.;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| The approval of an active substance that is considered as a candidate for substitution and each renewal shall be for a period not exceeding seven years.; | The approval of an active substance that is considered as a candidate for substitution and a one-time renewal shall be for a period not exceeding three years.; |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| The approval of an active substance that is considered as a candidate for substitution and each renewal shall be for a period not exceeding seven years.; | The approval of an active substance that is considered as a candidate for substitution and each renewal shall be for a period not exceeding ten years.; |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| The approval of an active substance that is considered as a candidate for substitution and each renewal shall be for a period not exceeding seven years.; | The approval of an active substance that is considered as a candidate for substitution and each renewal shall be for a period not exceeding ten years.; |
| Text proposed by the Commission | Amendment |
|---|---|
| The approval of an active substance that is considered as a candidate for substitution and each renewal shall be for a period not exceeding seven years.; | The approval of an active substance that is considered as a candidate for substitution and each renewal shall be for a period not exceeding ten years.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (5) In Article 12, paragraph (3) is replaced by the following: | deleted |
| ‘3. The renewal of an approval of an active substance shall be for an unlimited time for all product-types to which the approval applies, unless the active substance is identified as a candidate for substitution in accordance with Article 10 or a shorter period is specified in the implementing act adopted in accordance with Article 14(4), point (a), renewing such an approval.;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The renewal of an approval of an active substance shall be for an unlimited time for all product-types to which the approval applies, unless the active substance is identified as a candidate for substitution in accordance with Article 10 or a shorter period is specified in the implementing act adopted in accordance with Article 14(4), point (a), renewing such an approval.; | 3. The renewal of an approval of an active substance shall be for a period of 20 years for all product-types to which the approval applies, unless the active substance is identified as a candidate for substitution in accordance with Article 10 or a shorter period is specified in the implementing act adopted in accordance with Article 14(4), point (a), renewing such an approval.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The renewal of an approval of an active substance shall be for an unlimited time for all product-types to which the approval applies, unless the active substance is identified as a candidate for substitution in accordance with Article 10 or a shorter period is specified in the implementing act adopted in accordance with Article 14(4), point (a), renewing such an approval.; | 3. The renewal of an approval of an active substance shall be for 15 years time for all product-types to which the approval applies, unless the active substance is identified as a candidate for substitution in accordance with Article 10 or a shorter period is specified in the implementing act adopted in accordance with Article 14(4), point (a), renewing such an approval.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The renewal of an approval of an active substance shall be for an unlimited time for all product-types to which the approval applies, unless the active substance is identified as a candidate for substitution in accordance with Article 10 or a shorter period is specified in the implementing act adopted in accordance with Article 14(4), point (a), renewing such an approval.; | 3. The renewal of an approval of an active substance shall be 15 years for all product-types to which the approval applies, unless the active substance is identified as a candidate for substitution in accordance with Article 10 or a shorter period is specified in the implementing act adopted in accordance with Article 14(4), point (a), renewing such an approval.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (6) in Article 13, paragraph 1 is replaced by the following: | deleted |
| ‘1. Applicants wishing to seek renewal of the approval of an active substance, which is subject to a specified expiry date for one or more product-types, shall submit an application to the Agency at least 550 days before the expiry of the approval. Where there are different expiry dates for different product-types, the application shall be submitted at least 550 days before the earliest expiry date.;’ |
| Present text | Amendment |
|---|---|
| (6a) In Article 14, paragraph 5 is deleted | |
| 5. Where, for reasons beyond the control of the applicant, the approval of the active substance is likely to expire before a decision has been taken on its renewal, the Commission shall, by means of implementing acts, adopt a decision postponing the expiry date of approval for a period sufficient to enable it to examine the application. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 82(2). |
| Text proposed by the Commission | Amendment |
|---|---|
| (7) a new Article 14a is inserted: | deleted |
| ‘Article 14a | |
| Renewal of an active substance with unlimited approval | |
| 1. The Commission may adopt implementing acts in accordance with the examination procedure referred to in Article 82(3) identifying active substances with unlimited approval for which a renewal procedure shall be conducted. The implementing acts shall list the active substances and product-types concerned, and set the expiry date of their current approvals that allows for an evaluation of the applications and the adoption of a decision on the renewal of approval. | |
| Article 13 and Article 14 apply mutatis mutandis for the submission, acceptance and evaluation of the applications. | |
| 2. The identification of the active substances concerned shall take into account, among others, relevant new or updated data requirements or guidance documents, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data, and may take into account requests from Member States.;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (7) a new Article 14a is inserted: | deleted |
| ‘Article 14a | |
| Renewal of an active substance with unlimited approval | |
| 1. The Commission may adopt implementing acts in accordance with the examination procedure referred to in Article 82(3) identifying active substances with unlimited approval for which a renewal procedure shall be conducted. The implementing acts shall list the active substances and product-types concerned, and set the expiry date of their current approvals that allows for an evaluation of the applications and the adoption of a decision on the renewal of approval. | |
| Article 13 and Article 14 apply mutatis mutandis for the submission, acceptance and evaluation of the applications. | |
| 2. The identification of the active substances concerned shall take into account, among others, relevant new or updated data requirements or guidance documents, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data, and may take into account requests from Member States.;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 14a | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| Renewal of an active substance with unlimited approval | Renewal of a low-risk active substance and biocontrol with unlimited approval |
| Text proposed by the Commission | Amendment |
|---|---|
| Renewal of an active substance with unlimited approval | Renewal of an active substance with limited approval |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may adopt implementing acts in accordance with the examination procedure referred to in Article 82(3) identifying active substances with unlimited approval for which a renewal procedure shall be conducted. The implementing acts shall list the active substances and product-types concerned, and set the expiry date of their current approvals that allows for an evaluation of the applications and the adoption of a decision on the renewal of approval. | deleted |
Decisions on whether an active substance should undergo renewal should not be left to a discretionary work programme established by the Commission. Regular, predictable renewals based on fixed approval periods provide greater legal certainty, ensure that all active substances are periodically reassessed in the light of the latest scientific and technical knowledge, and better protect human health and the environment.
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may adopt implementing acts in accordance with the examination procedure referred to in Article 82(3) identifying active substances with unlimited approval for which a renewal procedure shall be conducted. The implementing acts shall list the active substances and product-types concerned, and set the expiry date of their current approvals that allows for an evaluation of the applications and the adoption of a decision on the renewal of approval. | The Commission may adopt implementing acts in accordance with the examination procedure referred to in Article 82(3) and after consulting the Agency, identifying active substances with unlimited approval for which a renewal procedure shall be conducted. The implementing acts shall list the active substances and product-types concerned, and set the expiry date of their current approvals that allows for an evaluation of the applications and the adoption of a decision on the renewal of approval. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may adopt implementing acts in accordance with the examination procedure referred to in Article 82(3) identifying active substances with unlimited approval for which a renewal procedure shall be conducted. The implementing acts shall list the active substances and product-types concerned, and set the expiry date of their current approvals that allows for an evaluation of the applications and the adoption of a decision on the renewal of approval. | The Commission may adopt implementing acts in accordance with the examination procedure referred to in Article 82(3) identifying active substances with limited approval for which a renewal procedure shall be conducted sooner. The implementing acts shall list the active substances and product-types concerned, and set the expiry date of their current approvals that allows for an evaluation of the applications and the adoption of a decision on the renewal of approval. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The identification of the active substances concerned shall take into account, among others, relevant new or updated data requirements or guidance documents, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data, and may take into account requests from Member States.; | 2. The identification of the active substances concerned shall take into account, among others, relevant new or updated data requirements or guidance documents, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data, and may take into account requests from Member States. New or updated guidance documents shall not, in themselves, introduce new data requirements or assessment criteria for applications already under evaluation, unless necessary to address a newly identified risk to human or animal health or the environment |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The identification of the active substances concerned shall take into account, among others, relevant new or updated data requirements or guidance documents, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data, and may take into account requests from Member States.; | 2. The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data, and may take into account requests from Member States. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The identification of the active substances concerned shall take into account, among others, relevant new or updated data requirements or guidance documents, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data, and may take into account requests from Member States.; | 2. The identification of the active substances concerned shall take into account, among others, relevant new or updated data requirements or guidance documents, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data, and shall take into account requests from Member States.; |
| Present text | Amendment |
|---|---|
| (7a) in Article 15, paragraph 1 is replaced by the following: | |
| 1. The Commission may review the approval of an active substance for one or more product-types at any time where there are significant indications that the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2) are no longer met. The Commission may also review the approval of an active substance for one or more product-types at the request of a Member State if there are indications that the use of the active substance in biocidal products or treated articles raises significant concerns about the safety of such biocidal products or treated articles. The Commission shall make publicly available the information that it is carrying out a review and shall provide an opportunity for applicant to submit comments. The Commission shall take due account of those comments in its review. Where those indications are confirmed, the Commission shall adopt an implementing Regulation amending the conditions of approval of an active substance or cancelling its approval. That implementing Regulation shall be adopted in accordance with the examination procedure referred to in Article 82(3). Article 9(2) shall apply. The Commission shall inform the initial applicants for the approval accordingly. On duly justified imperative grounds of urgency the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 82(4). | "1. The Commission may review the approval of an active substance for one or more product-types at any time where there are significant indications that the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2) are no longer met. The Commission shall also review the approval of an active substance for one or more product-types at the request of a Member State if there are indications that the use of the active substance in biocidal products or treated articles raises significant concerns about the safety of such biocidal products or treated articles. The Commission shall make publicly available the information that it is carrying out a review and shall provide an opportunity for applicant to submit comments. The Commission shall take due account of those comments in its review. Where those indications are confirmed, the Commission shall adopt an implementing Regulation amending the conditions of approval of an active substance or cancelling its approval. That implementing Regulation shall be adopted in accordance with the examination procedure referred to in Article 82(3). Article 9(2) shall apply. The Commission shall inform the initial applicants for the approval accordingly. On duly justified imperative grounds of urgency the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 82(4)." |
| Present text | Amendment |
|---|---|
| (7a) in Article 15, the first subparagraph of the paragraph 1 is replaced by the following: | |
| 1. The Commission may review the approval of an active substance for one or more product-types at any time where there are significant indications that the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2) are no longer met. The Commission may also review the approval of an active substance for one or more product-types at the request of a Member State if there are indications that the use of the active substance in biocidal products or treated articles raises significant concerns about the safety of such biocidal products or treated articles. The Commission shall make publicly available the information that it is carrying out a review and shall provide an opportunity for applicant to submit comments. The Commission shall take due account of those comments in its review. | "1. The Commission may review the approval of an active substance for one or more product-types at any time where there are significant indications in the light of new scientific, technical knowledge and monitoring data that the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2) are no longer met. The Commission shall act within 3 months to review the approval of an active substance for one or more product-types at the request of a Member State if there are indications that the use of the active substance in biocidal products or treated articles raises significant concerns about the safety of such biocidal products or treated articles. The Commission shall make publicly available the information that it is carrying out a review and shall provide an opportunity for applicant to submit comments. The Commission shall take due account of those comments in its review.” |
| Present text | Amendment |
|---|---|
| (7b) in Article 15, paragraph 2 is replaced by the following: | |
| 2. The Commission may consult the Agency on any questions of a scientific or technical nature related to the review of approval of an active substance. The Agency shall, within 270 days of the request, prepare an opinion and submit it to the Commission. | “2. The Authority shall be mandated in any case to provide scientific and technical assistance on the review of the approval. The Agency shall, within 270 days of the request, prepare an opinion and submit it to the Commission. " |
| Text proposed by the Commission | Amendment |
|---|---|
| (8) a new Article 15a is inserted: | deleted |
| ‘Article 15a | |
| Approval periods of active substances approved by [OP, please insert the date: date of the entry into force of this Regulation] | |
| For all active substances approved under Regulation (EU) No 528/2012 at the latest on [OP, please insert the date: date of the entry into force of this Regulation] for one or more product-types, approvals shall be deemed unlimited in time for the concerned product-types, except for: | |
| (a) active substances identified as meeting the criteria set out in Article 5(1) or Article 10; | |
| (b) active substances for which an application for renewal was submitted by the deadline set out in Article 13(1) by [OP, please insert the date: date of the entry into force of this Regulation]; | |
| (c) active substances for which no application for renewal was submitted by the deadline set out in Article 13(1) by [OP, please insert the date: date of the entry into force of this Regulation].;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 15a | deleted |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| For all active substances approved under Regulation (EU) No 528/2012 at the latest on [OP, please insert the date: date of the entry into force of this Regulation] for one or more product-types, approvals shall be deemed unlimited in time for the concerned product-types, except for: | deleted |
| (a) active substances identified as meeting the criteria set out in Article 5(1) or Article 10; | |
| (b) active substances for which an application for renewal was submitted by the deadline set out in Article 13(1) by [OP, please insert the date: date of the entry into force of this Regulation]; | |
| (c) active substances for which no application for renewal was submitted by the deadline set out in Article 13(1) by [OP, please insert the date: date of the entry into force of this Regulation].; |
Automatically converting existing approvals into unlimited approvals would remove the principle of periodic scientific reassessment that underpins the Union's regulatory framework for biocidal active substances. Active substances should continue to be subject to regular renewal in order to ensure that approvals remain based on the latest scientific and technical knowledge and continue to provide a high level of protection of human health and the environment.
| Text proposed by the Commission | Amendment |
|---|---|
| For all active substances approved under Regulation (EU) No 528/2012 at the latest on [OP, please insert the date: date of the entry into force of this Regulation] for one or more product-types, approvals shall be deemed unlimited in time for the concerned product-types, except for: | For all active substances approved under Regulation (EU) No 528/2012 at the latest on [OP, please insert the date: date of the entry into force of this Regulation] for one or more product-types, approvals shall be deemed for an initial period not exceeding 10 years if at least one biocidal product containing that active substance may be expected to meet the criteria laid down in point (b) of Article 19(1) taking into account the factors set out in Article 19(2) and (5). An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years, except for: |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) active substances identified as meeting the criteria set out in Article 5(1) or Article 10; | (a) active substances identified as meeting the exclusion or substitution criteria set out in Article 5(1) or Article 10; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) active substances for which a review of approval in accordance with Article 15 is ongoing on the date [OP, please insert the date: date of the entry into force of this Regulation]; | |
| (cb) active substances whose approval has not yet been renewed at least once in accordance with Article 12; | |
| (cc) active substances for which a reduced period is set in accordance with Article 4 (3)(g) and (h); | |
| (cd) active substances, classified in accordance with the provisions of the Regulation EC No 1272/2008, as carcinogen category 2, mutagen category 2 or toxic for reduction category 2; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) active substances for which a review of approval in accordance with Article 15 is ongoing on [OP, please insert the date: date of the entry into force of this Regulation]; |
| Text proposed by the Commission | Amendment |
|---|---|
| (cb) active substances whose approval has not yet been renewed at least once in accordance with Article 12; |
| Text proposed by the Commission | Amendment |
|---|---|
| (cc) active substances for which a reduced period is set in accordance with Article 4 (3)(g) and (h); |
| Text proposed by the Commission | Amendment |
|---|---|
| (cd) active substances, classified in accordance with the provisions of the Regulation EC No 1272/2008, as carcinogen category 2, mutagen category 2 or toxic for reproduction category 2; |
| Present text | Amendment |
|---|---|
| (8a) Article 17(1) is amended as follows: | |
| 1. Biocidal products shall not be made available on the market or used unless authorised in accordance with this Regulation. | 1. Biocidal products shall not be made available on the market or used unless authorised in accordance with this Regulation. Biocidal products may also be made available on the market and used in agriculture where their application falls under health-related biocidal use in agriculture within the meaning of Article 3(1), point (af), provided that they are authorised in accordance with this Regulation.’ |
| Present text | Amendment |
|---|---|
| (8a) Article 17(1) is amended as follows: | |
| 1. Biocidal products shall not be made available on the market or used unless authorised in accordance with this Regulation. | 1. Biocidal products shall not be made available on the market or used unless authorised in accordance with this Regulation. Biocidal products may also be made available on the market and used in agriculture where their application falls under health-related biocidal use in agriculture within the meaning of Article 3(1), point (af), provided that they are authorised in accordance with this Regulation. |
| Present text | Amendment |
|---|---|
| (8a) Article 17, paragraph 4 is replaced by the following: | |
| 4. An authorisation shall be granted for a maximum period of 10 years. | "4. An authorisation shall be granted for a maximum period of 10 years. An authorisation for product-types 1-5 and 8 shall be granted for 25 years. Article 88 applies without prejudice." |
This amendment provides for a longer authorisation period for biocidal products in product-types 1–5 (disinfectants) and product-type 8 (wood preservatives), while retaining the general 10-year authorisation period for all other product-types.Disinfectants are essential for protecting public health, while wood preservatives contribute to the objectives of the European Green Deal and the Circular Economy by extending the lifespan of wood products, reducing resource use and waste, and lowering greenhouse gas emissions. Extending the authorisation period for these product-types would also reduce unnecessary administrative burdens for competent authorities and industry, particularly for European SMEs, and supports the Union's broader objective of regulatory simplification. The amendment does not weaken regulatory oversight. In accordance with Article 88 of Regulation (EU) No 528/2012, Member States retain the power to review, amend or cancel an authorisation at any time where new information indicates that a product no longer fulfils the conditions for authorisation or presents unacceptable risks to human health or the environment.
| Present text | Amendment |
|---|---|
| (8a) in Article 17, paragraph 4 is replaced by the following: | |
| 4. An authorisation shall be granted for a maximum period of 10 years. | "4. An authorization shall be granted for an unlimited period. Article 88 applies without prejudice." |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (8a) Article 17, paragraph 4 is replaced by the following: | |
| "4. An authorization shall be granted for an unlimited period. Article 88 applies without prejudice." |
| Text proposed by the Commission | Amendment |
|---|---|
| (8a) in Article 17, paragraph 4 is replaced by the following: | |
| “4. An authorisation shall be granted for an unlimited time.” |
Aligning the duration of biocidal product authorisations with the approval cycle of the active substances they contain would improve regulatory coherence and predictability, while reducing unnecessary administrative burden from repetitive renewal procedures. Existing BPR safeguards would continue to ensure an appropriate level of protection, while allowing resources to be redirected towards innovation and more sustainable solutions.
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Present text | Amendment |
|---|---|
| (8a) In Article 17, paragraph (4) is replaced by the following: | |
| 4. An authorisation shall be granted for a maximum period of 10 years. | "4. An authorisation shall be granted for an unlimited time." |
| Text proposed by the Commission | Amendment |
|---|---|
| (8b) in Article 19, the following paragraph is inserted: | |
| ‘1a. Member States may authorise health-related biocidal uses in agriculture, in particular for products intended for the control of rodents and other unhygienic pests and, where appropriate, certain insecticides that are classed as the relevant product type, when: | |
| (a) there is a proven risk to the health of humans or animals; | |
| (b) that use does not have crop protection as its primary objective; | |
| (c) strict conditions are imposed with regard to use, monitoring and risk reduction; | |
| (d) if applicable, the structural, climate and health constraints of the outermost regions referred to in Article 349 of the Treaty on the Functioning of the European Union have been taken into account.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (8b) in Article 19, the following paragraph is inserted: | |
| ‘1a. Member States may authorise health-related biocidal uses in agriculture, in particular for products intended for the control of rodents and other unhygienic pests and, where appropriate, certain insecticides that are classed as the relevant product type, when: (a) there is a proven risk to the health of humans or animals; (b) that use does not have crop protection as its primary objective; (c) strict conditions are imposed with regard to use, monitoring and risk reduction; (d) if applicable, the structural, climate and health constraints of the outermost regions referred to in Article 349 of the Treaty on the Functioning of the European Union have been taken into account.’ |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Present text | Amendment |
|---|---|
| (8b) In Article 19, paragraph (5) is replaced by the following: | |
| 5. Notwithstanding paragraphs 1 and 4, a biocidal product may be authorised when the conditions laid down in paragraph 1(b)(iii) and (iv) are not fully met, or may be authorised for making available on the market for use by the general public when the criteria referred to in paragraph 4(c) are met, where not authorising the biocidal product would result in disproportionate negative impacts for society when compared to the risks to human health, animal health or the environment arising from the use of the biocidal product under the conditions laid down in the authorisation.The use of a biocidal product authorised pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment to that biocidal product is minimised. The use of a biocidal product authorised pursuant to this paragraph shall be restricted to Member States in which the condition of the first subparagraph is met. | "5. Notwithstanding paragraphs 1 and 4, a biocidal product may be authorised when the conditions laid down in paragraph 1(b)(iii) and (iv) are not fully met, or may be authorised for making available on the market for use by the general public, where not authorising the biocidal product would result in disproportionate negative impacts for society when compared to the risks to human health, animal health or the environment arising from the use of the biocidal product under the conditions laid down in the authorisation. Based on a risk assessment, the use of a biocidal product authorised pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment to that biocidal product is minimised. The use of a biocidal product authorised pursuant to this paragraph shall be restricted to Member States in which the condition of the first subparagraph is met." |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Present text | Amendment |
|---|---|
| (8c) in Article 23, paragraph 6 is replaced by the following: | |
| Notwithstanding Article 17(4), and without prejudice to paragraph 4 of this Article, an authorisation for a biocidal product containing an active substance that is a candidate for substitution shall be granted for a period not exceeding five years and renewed for a period not exceeding five years. | "Notwithstanding Article 17(4), and without prejudice to paragraph 4 of this Article, an authorisation for a biocidal product containing an active substance that is a candidate for substitution shall be granted for a period not exceeding ten years and renewed for a period not exceeding ten years." |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Present text | Amendment |
|---|---|
| (8d) In Article 31, paragraph (1) is replaced by the following: | |
| 1. An application by or on behalf of an authorisation holder wishing to seek the renewal of a national authorisation for one or more product-types shall be submitted to the receiving competent authority at least 550 days before the expiry date of the authorisation. Where renewal is sought for more than one product-type, the application shall be submitted at least 550 days before the earliest expiry date. | "1. The renewal of an authorisation shall be for an unlimited time for all product-types to which the authorisation applies, unless the biocidal product contains an active substance that is candidate for substitution in accordance with Article 10. An application by or on behalf of an authorisation holder wishing to seek the renewal of a national authorisation, which is subject to a specified expiry date for one or more product-types shall be submitted to the receiving competent authority at least 550 days before the expiry date of the authorisation. Where renewal is sought for more than one product-type, the application shall be submitted at least 550 days before the earliest expiry date." |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| Upon receipt of the opinion of the Agency, the Commission shall adopt either an implementing act granting the Union authorisation of the biocidal product or an implementing act stating that the Union authorisation of the biocidal product has not been granted. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3). | Within 180 days of receipt of the opinion of the Agency, the Commission shall adopt either an implementing act granting the Union authorisation of the biocidal product or an implementing act stating that the Union authorisation of the biocidal product has not been granted. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3) and notified to the applicants. |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Present text | Amendment |
|---|---|
| (9a) In Article 45, paragraph (1) is replaced by the following: | |
| 1. An application by or on behalf of an authorisation holder wishing to seek the renewal of a Union authorisation shall be submitted to the Agency at least 550 days before the expiry date of the authorisation. | "1. An application by or on behalf of an authorisation holder wishing to seek the renewal of a Union authorisation, which is subject to a specified expiry date, shall be submitted to the Agency at least 550 days before the expiry date of the authorisation. |
| The application shall be accompanied by the fees payable under Article 80(1).” |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| Upon receipt of the opinion of the Agency, the Commission shall adopt an implementing act renewing the Union authorisation or refusing to renew the Union authorisation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).. | Within 180 days of receipt of the opinion of the Agency, the Commission shall adopt an implementing act renewing the Union authorisation or refusing to renew the Union authorisation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).. |
| Text proposed by the Commission | Amendment |
|---|---|
| (10a) a new Article 55a is inserted: | |
| "Article 55a | |
| Temporary authorisation of biocidal use for sanitary purposes in agricultural environments | |
| Where a serious sanitary risk or a major infestation of pests in an agricultural environment creates an immediate threat to human or animal health, a Member State may, for a limited period and subject to strict conditions, grant a temporary authorisation for the use of a biocidal product falling within the scope of this Regulation, even where such use is not yet covered by an appropriate standard authorisation. The Member State shall immediately notify the Commission and the Agency, specifying the sanitary justification, the geographical area concerned, the duration of the authorisation, the conditions of use and the risk mitigation measures applied." |
| Text proposed by the Commission | Amendment |
|---|---|
| (10a) the following Article is inserted: | |
| ‘Article 55a | |
| Temporary authorisation for health-related biocidal use in agriculture | |
| In the event of a serious health risk or major pest infestation in agricultural settings posing an immediate threat to human or animal health, a Member State may temporarily authorise, for a limited time and under strict conditions, the use of a biocidal product covered by this Regulation, even if that use is not yet covered by an appropriate standard authorisation. The Member State shall, without delay, notify the Commission and the Agency of the measure, specifying the health justification, the area concerned, the duration, the conditions of use and the risk reduction measures.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (10a) the following Article 55a is inserted: | |
| Temporary authorisation for health-related biocidal use in agriculture | |
| In the event of a serious health risk or major pest infestation in agricultural settings posing an immediate threat to human or animal health, a Member State may temporarily authorise, for a limited time and under strict conditions, the use of a biocidal product covered by this Regulation, even if that use is not yet covered by an appropriate standard authorisation. | |
| The Member State shall, without delay, notify the Commission and the Agency of the measure, specifying the health justification, the area concerned, the duration, the conditions of use and the risk reduction measures. |
| Present text | Amendment |
|---|---|
| (10a) In Article 89, a new paragraph 4a is added: | |
| "4a. Where a complete application for the approval of an active substance or for product authorisation under this Regulation was submitted before 31 December 2019 and has been validated as complete by the competent authority, Member States may allow the continued making available on the market and use of the biocidal product concerned until a final decision has been adopted, provided that: | |
| (a) no unacceptable risk to human health, animal health or the environment has been identified based on the available scientific evidence; | |
| (b) the applicant continues to provide any supplementary information requested within the prescribed deadlines; and | |
| (c) risk mitigation measures considered necessary by the evaluating competent authority are applied. | |
| The Commission may adopt implementing acts to lay down harmonised conditions for such continued use. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 5 | deleted |
| Amendment to Regulation (EC) No 1829/2003 | |
| Regulation (EC) No 1829/2003 is amended as follows: | |
| in Article 2, point (10), the following is added: | |
| ‘Food and feed which are obtained using as production strains genetically modified micro-organisms within the meaning of Art 2(b) of Directive 2009/41/EC, with the exception of animal and plant cells in culture, are not food and feed ‘produced from GMOs’ where they do not contain those micro-organisms and, if they contain residues thereof, such residues are limited to non-viable cells, their presence is minimized through reasonable attempts to remove them in accordance with good manufacturing practice and they have no technological effect on the food or the feed.. ’ |
| Text proposed by the Commission | Amendment |
|---|---|
| Food and feed which are obtained using as production strains genetically modified micro-organisms within the meaning of Art 2(b) of Directive 2009/41/EC, with the exception of animal and plant cells in culture, are not food and feed ‘produced from GMOs’ where they do not contain those micro-organisms and, if they contain residues thereof, such residues are limited to non-viable cells, their presence is minimized through reasonable attempts to remove them in accordance with good manufacturing practice and they have no technological effect on the food or the feed.. | Food and feed which are produced with the assistance of genetically modified micro-organisms within the meaning of Art 2(b) of Directive 2009/41/EC, with the exception of animal and plant cells in culture, are not food and feed ‘produced from GMOs’ where |
| (a) they do not contain viable cells of those micro-organisms and, | |
| (b) if they contain residues of such genetically modified micro-organisms, such residues meet all the following conditions: | |
| (i) they are non-viable; | |
| (ii) their presence is minimized through reasonable attempts to remove them in accordance with good manufacturing practice used in similar food and feed products, and | |
| (iii) they have no technological effect on the food or the feed.. |
Biljana Borzan, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Thomas Bajada, Mohammed Chahim
| Text proposed by the Commission | Amendment |
|---|---|
| Food and feed which are obtained using as production strains genetically modified micro-organisms within the meaning of Art 2(b) of Directive 2009/41/EC, with the exception of animal and plant cells in culture, are not food and feed ‘produced from GMOs’ where they do not contain those micro-organisms and, if they contain residues thereof, such residues are limited to non-viable cells, their presence is minimized through reasonable attempts to remove them in accordance with good manufacturing practice and they have no technological effect on the food or the feed.. | Food and feed which are obtained using as production strains genetically modified micro-organisms within the meaning of Article 2(b) of Directive 2009/41/EC, with the exception of animal and plant cells in culture, or novel foods that intend to recreate animal products from GMMs are not food and feed ‘produced from GMOs’ where they do not contain those micro-organisms and, if they contain residues thereof, such residues are limited to technically unavoidable non-viable cells, their presence is minimised in accordance with good manufacturing practice and they have no technological effect on the food or the feed. This shall be without prejudice to applicable Union requirements on traceability and consumer information. |
The exemption from the definition of food and feed "produced from GMOs" should remain limited to products obtained using genetically modified micro-organisms as processing aids. Novel foods intended to recreate animal products through fermentation rely on genetically modified micro-organisms as the essential production system rather than as a mere processing aid.Consumers and competent authorities should continue to benefit from clear information and traceability where provided for under Union law. Only technically unavoidable residues may remain in the final product.
| Text proposed by the Commission | Amendment |
|---|---|
| Food and feed which are obtained using as production strains genetically modified micro-organisms within the meaning of Art 2(b) of Directive 2009/41/EC, with the exception of animal and plant cells in culture, are not food and feed ‘produced from GMOs’ where they do not contain those micro-organisms and, if they contain residues thereof, such residues are limited to non-viable cells, their presence is minimized through reasonable attempts to remove them in accordance with good manufacturing practice and they have no technological effect on the food or the feed.. | Produced from GMOs’ means derived, in whole or in part, from GMOs; except that food and feed are not considered produced from genetically modified micro-organisms as defined in Art 2(b) of Directive 2009/41/EC, when they meet the following criteria: |
| (a) they do not contain such viable genetically modified micro-organisms; and, | |
| (b) if they contain residual material of such genetically modified micro-organisms, such residual material meets all the following conditions: | |
| (i) it is non-viable; | |
| (ii) the product is processed with good manufacturing practice; and | |
| (iii) it has no technological effect on the food or the feed; |
| Text proposed by the Commission | Amendment |
|---|---|
| Food and feed which are obtained using as production strains genetically modified micro-organisms within the meaning of Art 2(b) of Directive 2009/41/EC, with the exception of animal and plant cells in culture, are not food and feed ‘produced from GMOs’ where they do not contain those micro-organisms and, if they contain residues thereof, such residues are limited to non-viable cells, their presence is minimized through reasonable attempts to remove them in accordance with good manufacturing practice and they have no technological effect on the food or the feed.. | Food and feed which are obtained using as production strains genetically modified micro-organisms within the meaning of Art 2(b) of Directive 2009/41/EC, with the exception of animal and plant cells in culture or novel food that intend to recreate animal products from GMMs, are not food and feed ‘produced from GMOs’ where they do not contain those micro-organisms and, if they contain residues thereof, such residues are limited to non-viable cells, their presence is minimized through reasonable attempts to remove them in accordance with good manufacturing practice and they have no technological effect on the food or the feed.. |
Food products from GMM. The proposed text raises concerns regarding fermentation and the scope of the exemption from GMO legislation under Regulation (EC) No 1829/2003. Both Regulation 1829/2003 and the Commission’s 2006 report refer to genetically modified microorganisms used as processing aids (e.g. enzymes or additives). The Commission’s proposed clarification, however, appears to broaden this concept to cover any GMO used in production. In fermentation processes for synthetic milk, GM microorganisms are not processing aids but the actual producers of the final product. The product is therefore produced by GMOs, not merely with their support. Treating such uses as exempt would be comparable to authorising the marketing of milk produced by a genetically modified cow.
| Text proposed by the Commission | Amendment |
|---|---|
| Food and feed which are obtained using as production strains genetically modified micro-organisms within the meaning of Art 2(b) of Directive 2009/41/EC, with the exception of animal and plant cells in culture, are not food and feed ‘produced from GMOs’ where they do not contain those micro-organisms and, if they contain residues thereof, such residues are limited to non-viable cells, their presence is minimized through reasonable attempts to remove them in accordance with good manufacturing practice and they have no technological effect on the food or the feed.. | Food and feed which are obtained using as production strains genetically modified micro-organisms within the meaning of Art 2(b) of Directive 2009/41/EC, with the exception of animal and plant cells in culture or novel food that intend to recreate animal products from GMMs, are not food and feed ‘produced from GMOs’ where they do not contain those micro-organisms and, if they contain residues thereof, such residues are limited to non-viable cells, their presence is minimized through reasonable attempts to remove them in accordance with good manufacturing practice and they have no technological effect on the food or the feed. |
This amendment clarifies that novel foods recreating animal products through genetically modified microorganisms should not benefit from the exemption, as these products are produced from GMOs rather than merely using GMOs as processing aids.
| Text proposed by the Commission | Amendment |
|---|---|
| Food and feed which are obtained using as production strains genetically modified micro-organisms within the meaning of Art 2(b) of Directive 2009/41/EC, with the exception of animal and plant cells in culture, are not food and feed ‘produced from GMOs’ where they do not contain those micro-organisms and, if they contain residues thereof, such residues are limited to non-viable cells, their presence is minimized through reasonable attempts to remove them in accordance with good manufacturing practice and they have no technological effect on the food or the feed.. | Food and feed which are obtained using as production strains genetically modified micro-organisms within the meaning of Art 2(b) of Directive 2009/41/EC, with the exception of animal and plant cells in culture or novel food that intend to recreate animal products from GMMs, are not food and feed ‘produced from GMOs’ where they do not contain those micro-organisms and, if they contain residues thereof, such residues are limited to non-viable cells, their presence is minimized through reasonable attempts to remove them in accordance with good manufacturing practice and they have no technological effect on the food or the feed.. |
| Text proposed by the Commission | Amendment |
|---|---|
| Food and feed which are obtained using as production strains genetically modified micro-organisms within the meaning of Art 2(b) of Directive 2009/41/EC, with the exception of animal and plant cells in culture, are not food and feed ‘produced from GMOs’ where they do not contain those micro-organisms and, if they contain residues thereof, such residues are limited to non-viable cells, their presence is minimized through reasonable attempts to remove them in accordance with good manufacturing practice and they have no technological effect on the food or the feed.. | Food and feed which are obtained using as production strains genetically modified micro-organisms within the meaning of Art 2(b) of Directive 2009/41/EC, with the exception of animal and plant cells in culture, are not food and feed ‘produced from GMOs’ where they do not contain those micro-organisms and, if they contain residues thereof, such residues are limited to non-viable cells, their presence is minimized through reasonable attempts to remove them in accordance with good manufacturing practice. |
It is not reasonable to include wording that prevents a technological effect, since the change being made is a technical one.
Benoit Cassart, Gerben-Jan Gerbrandy, Martin Hojsík, Christine Singer, Pascal Canfin, Olivier Chastel, Michal Wiezik, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| Food and feed which are obtained using as production strains genetically modified micro-organisms within the meaning of Art 2(b) of Directive 2009/41/EC, with the exception of animal and plant cells in culture, are not food and feed ‘produced from GMOs’ where they do not contain those micro-organisms and, if they contain residues thereof, such residues are limited to non-viable cells, their presence is minimized through reasonable attempts to remove them in accordance with good manufacturing practice and they have no technological effect on the food or the feed.. | Food and feed which are obtained using as production strains genetically modified micro-organisms within the meaning of Art 2(b) of Directive 2009/41/EC, with the exception of animal and plant cells in culture, are not food and feed ‘produced from GMOs’ where they do not contain those micro-organisms and, if they contain residues thereof, such residues are limited to non-viable cells, their presence is minimized through as low as reasonably achievable attempts to remove them in accordance with good manufacturing practice and they have no technological effect on the food or the feed.. |
| Text proposed by the Commission | Amendment |
|---|---|
| (1a) In Article 2, the following new point 16a is added: | |
| '16a. ‘fermentation product’ means a product which is produced by fermentation using genetically modified micro-organisms as a processing aid and in which the genetically modified micro-organism is neither present in the final product as a viable organism nor passes into the final product as an ingredient and/or component.' |
| Text proposed by the Commission | Amendment |
|---|---|
| (1a) In Article 5, the following paragraph 7a is added: | |
| "7a. For fermentation products referred to in Article 2, a notification shall be made to the Commission prior to placing them on the market. | |
| The notification shall include at least: | |
| (a) a description of the manufacturing process; | |
| (b) the identity of the micro-organism used as a processing aid; | |
| (c) evidence that the micro-organism is not present as a viable organism in the final product and does not pass over as an ingredient and/or component; | |
| (d) a summary of the self-monitoring and traceability measures. | |
| The Commission shall keep a public register of notifications. Within 60 days, the Commission may, after consulting the Authority, raise reasoned objections where there are indications that the conditions laid down in subparagraph 2 are not met. In that case, the authorisation procedure laid down in this Regulation shall apply." |
| Text proposed by the Commission | Amendment |
|---|---|
| (1a) In Article 5, the following new paragraph 7a is added: | |
| “7a. Fermentation products within the meaning of Article 2 must be notified to the Commission prior to being placed on the market. The notification shall include at least | |
| a) a description of the manufacturing process; | |
| b) the identity of the micro-organism used as a processing aid; | |
| c) evidence that the micro-organism is not present as a viable organism in the final product and does not carry over as an ingredient and/or component; | |
| d) a summary of the self-monitoring and traceability measures. | |
| The Commission shall maintain a public register of notifications. Within 60 days, the Commission may, after consulting the authority, raise reasoned objections if there are grounds to believe that the conditions set out in paragraph 2 are not met. In such a case, the authorisation procedure laid down in this regulation shall apply." |
| Text proposed by the Commission | Amendment |
|---|---|
| (1b) In Article 22, the following new paragraph 3a is added: | |
| "3a. For changes that exclusively concern: | |
| (a) the name and/or address of the marketing authorisation holder; | |
| (b) the form of presentation and/or format of information, including information provided in digital format; | |
| (c) or other relevant administrative information which have no impact on the risk assessment; | |
| a notification to the Commission shall suffice. The Commission shall update the Union Registry accordingly. A new risk assessment shall not be carried out as it is not necessary." |
| Text proposed by the Commission | Amendment |
|---|---|
| (1b) In Article 22, the following new paragraph 3a is added: | |
| “3a. For variations relating exclusively to: | |
| (a) the name and/or address of the marketing authorisation holder, | |
| (b) the presentation and/or format of information, including digital provision, | |
| (c) or other administrative details, and which have no impact on the risk assessment, | |
| a notification to the Commission shall suffice. The Commission shall update the Union Register. A new risk assessment is not required." |
Simplifying the process for making changes to existing authorisations in relation to non-risk-relevant data and information can ease the burden on companies and authorities through the introduction of a simplified procedure.
| Text proposed by the Commission | Amendment |
|---|---|
| (1c) In Article 23 the following new paragraph 6a is added: | |
| "6a. When renewing the authorisation, only new information which has been generated since the initial authorisation or the last renewal and which may be relevant to the risk assessments shall be provided. A full reassessment shall only be carried out if there are substantiated scientific indications of new or changed risks." |
| Text proposed by the Commission | Amendment |
|---|---|
| (2a) in Article 3, the following paragraph 5a is added: | |
| ‘By way of derogation from paragraph 1, this Regulation shall not prevent the manufacture, holding, storage, packaging, transfer of ownership, transport within the Union or export of feed additives not authorised in the Union, or of feed containing such additives, provided that they are intended exclusively for export to third countries, are clearly identified as intended for export and are not used in the feed chain in the Union.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| A Regulation granting authorisation for additives consisting of, containing or produced from GMOs shall include, where appropriate, the unique identifier attributed to the GMO as referred to in Regulation (EC) No 1830/2003 of the European Parliament and of the Council*’; | A Regulation granting authorisation for additives belonging to categories (d) and (e) referred to in Article 6(1) and also for additives consisting of, containing or produced from GMOs shall include, where appropriate, the unique identifier attributed to the GMO as referred to in Regulation (EC) No 1830/2003 of the European Parliament and of the Council*’; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) paragraph 8 is replaced by the following: | deleted |
| ‘8. Without prejudice to Article 13, the authorisation granted in accordance with the procedure laid down in this Regulation shall be valid for an unlimited period of time throughout the Union. The authorised feed additive shall be entered in the Community Register of Feed Additives referred to in Article 17 (‘the Register’) ) upon the entry into force of the Regulation granting the authorisation. Each entry in the Register shall state the date of authorisation and shall include the particulars referred to in paragraphs 5, 6 and 7 of this Article. In addition, each entry in the Register concerning additives belonging to categories provided for under points (d) and (e) of Article 6(1), and additives consisting of, containing or produced from GMOs, shall include the name of the holder of the authorisation.;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| 8b. By way of derogation from paragraph 8, the authorisation granted to additives belonging to the category provided for under point (e) of Article 6(1) in accordance with the procedure laid down in this Regulation shall be valid throughout the Union for 10 years and shall be renewable in accordance with Article 14.; | 8b. By way of derogation from paragraph 8, the authorisation granted to additives belonging to the category provided for under points (d) and (e) of Article 6(1) in accordance with the procedure laid down in this Regulation shall be valid throughout the Union for 10 years and shall be renewable in accordance with Article 14.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (5) the following new Article 9a is inserted: | deleted |
| ‘Article 9a | |
| Authorisation periods of certain authorisations granted before [OP: please insert the date = date of entry into force of this Regulation] | |
| Authorisations of feed additives granted before [OP: please insert the date = date of entry into force of this Regulation], shall be deemed to be unlimited in time, except for: | |
| (a) feed additives belonging to the category provided for in point (e) of Article 6(1); | |
| (b) urgent authorisations granted under Article 15; | |
| (c) authorisations for which no application for renewal has been submitted by the deadline set out in Article 14(1) before [OP: please insert the date = date of entry into force of this Regulation] or for which such application has been submitted but subsequently withdrawn; | |
| (d) authorisations for which an application for renewalhas been submitted in accordance with Article 14 before [OP: please insert the date = date of entry into force of this Regulation] and for which no decision has been taken by that date.;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) feed additives belonging to the category provided for in point (e) of Article 6(1); | (a) feed additives belonging to the category provided for in points (d) and (e) of Article 6(1); |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Commission shall examine the opinion of the Authority without delay. It shall, by means of implementing acts, take a decision on the modification, suspension or revocation of the authorisation concerned. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). | 2. The Commission shall examine the opinion of the Authority without delay. Any appropriate measures shall be taken in accordance with Articles 53 and 54 of Regulation (EC) No 178/2002. The Commission shall, by means of implementing acts, take a decision on the modification, suspension or revocation of the authorisation concerned. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Authorisations granted under this Regulation to additives belonging to the category provided for in point (e) of Article 6(1) may be renewed for 10-year periods. An application for renewal shall be sent to the Commission by the holder of the authorisation or his legal successor or successors, who shall be deemed to be the applicant, at the latest one year before the expiry date of the authorisation. | 1. Authorisations granted under this Regulation to additives belonging to the category provided for in points (d) and (e) of Article 6(1) may be renewed for 10-year periods. An application for renewal shall be sent to the Commission by the holder of the authorisation or his legal successor or successors, who shall be deemed to be the applicant, at the latest one year before the expiry date of the authorisation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. At the same time as it sends the application, the applicant shall send the following to the Authority: | 2. When considering the extension of an application, the assessment shall be limited to new or updated information relevant to safety, efficacy or consumer protection which has been generated since the last authorisation. A complete reassessment shall only be carried out if there are substantiated scientific indications of new or changed risks. At the same time as it sends the application, the applicant shall send the following to the Authority: |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. At the same time as it sends the application, the applicant shall send the following to the Authority: | 2. When assessing an application for renewal, the evaluation shall be limited to new or updated information relevant to safety, efficacy or consumer protection that has become available since the last authorisation. A full re-evaluation shall only be carried out if there is substantiated scientific evidence of new or changed risks. At the same time as it sends the application, the applicant shall send the following to the Authority: |
The amendment embeds a risk-based approach within the legal framework for feed additives in order to prevent unnecessary full-scale proceedings, conserve resources within businesses and public authorities, and enable a greater focus on risk-relevant proceedings
| Text proposed by the Commission | Amendment |
|---|---|
| 4. Where, for reasons beyond the control of the applicant, no decision is taken on the renewal of an authorisation before its expiry date, the period of authorisation of the product shall be automatically extended until the Commission takes a decision. Information on such extension shall be made available to the public in the Register.; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| Where labelling information for feed additives and premixtures is already mandatory under Regulation (EC) No 767/2009, such information shall not be repeatedly gathered under this Regulation, provided that the equivalence of information is ensured. |
| Text proposed by the Commission | Amendment |
|---|---|
| The requirements for hygiene, registration, approval and traceability of establishments remain unaffected. Information on the type-approval number shall be provided in accordance with Regulation (EC) No 183/2005. Labelling obligations in connection with genetically-modified organisms ('GMO') parts or components produced from GMOs are governed by Regulation (EC) No 1829/2003. This Regulation does not impose any additional or differing labelling requirements. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where labelling requirements for feed additives and premixtures are already mandatory under Regulation (EC) No 767/2009, these details need not be repeated under this Regulation, provided that the equivalence of the information is ensured. |
The amendment provides legal clarity by avoiding unnecessary duplication of labelling requirements where equivalent information is already required under the horizontal feed labelling legislation (Regulation (EC) No 767/2009). It does not affect the existing requirements on feed hygiene, establishment approval and traceability under Regulation (EC) No 183/2005, nor the labelling requirements for genetically modified feed under Regulation (EC) No 1829/2003.
| Text proposed by the Commission | Amendment |
|---|---|
| The requirements relating to hygiene, registration/authorisation and traceability of establishments remain unaffected. Information on the establishment approval number shall be provided in accordance with Regulation (EC) No 183/2005. Labelling requirements relating to GMO content or ingredients produced from GMOs are governed by Regulation (EC) No 1829/2003. This Regulation does not establish any additional or different labelling requirements. |
The amendment provides legal clarity by avoiding unnecessary duplication of labelling requirements where equivalent information is already required under the horizontal feed labelling legislation (Regulation (EC) No 767/2009). It does not affect the existing requirements on feed hygiene, establishment approval and traceability under Regulation (EC) No 183/2005, nor the labelling requirements for genetically modified feed under Regulation (EC) No 1829/2003.
| Text proposed by the Commission | Amendment |
|---|---|
| In the case of premixtures, points (b), (d), (e) and (g) shall not apply to the incorporated feed additives. | In the case of premixtures, points (b), (d), (e) and (g) shall not apply to the incorporated feed additives, unless the information referred to in those points is necessary to ensure the safe use or handling of the incorporated feed additive. |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from the first subparagraph, the information referred to in points (b), (d) and (g) may be provided by digital means | By way of derogation from the first subparagraph, the information referred to in points (b), (d) and (g) may be provided by digital means, provided that essential safety information and conditions of use remain directly available on the physical label. |
Digital labelling can reduce administrative burden and facilitate access to more detailed information. However, essential safety information and conditions of use should remain directly available on the physical label to ensure immediate accessibility for users, facilitate official controls and maintain a high level of feed safety.
Biljana Borzan, Christophe Clergeau, Gheorghe Cârciu, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Thomas Bajada, Mohammed Chahim
| Text proposed by the Commission | Amendment |
|---|---|
| 3. For flavouring compounds, the list of additives may be replaced by the words ‘mixture of flavouring compounds’. This shall not apply to flavouring compounds subject to a quantitative limitation when used in feed. | deleted |
Replacing the list of flavouring compounds with the generic description “mixture of flavouring compounds” would reduce transparency and limit the information available to users and competent authorities. Maintaining the requirement to identify flavouring compounds supports traceability, facilitates official controls and contributes to a high level of feed safety.
| Text proposed by the Commission | Amendment |
|---|---|
| 4. In addition to the information specified in paragraph 2, the label attached to the packaging or container of an additive belonging to a functional group specified in Annex III or of a premixture containing an additive belonging to a functional group specified in Annex III shall bear the information provided for in point 1, point 2(a)(i) and 2(b)(i) of that Annex, presented in a conspicuous, clearly legible and indelible manner. | 4. In addition to the information specified in paragraph 2, the label attached to the packaging or container of an additive belonging to a functional group specified in Annex III or of a premixture containing an additive belonging to a functional group specified in Annex III shall bear the information provided for in of that Annex, presented in a conspicuous, clearly legible and indelible manner. |
The current wording should be maintained to ensure that all relevant labelling requirements set out in Annex III continue to apply. Limiting the obligation to specific points of Annex III risks excluding other information that may be necessary for the safe and appropriate use of certain feed additives.
| Text proposed by the Commission | Amendment |
|---|---|
| (a) made available on a physical label to the competent authority upon request; | (a) made available on a physical label to all users of the additive or premixture and to competent authorities upon request throughout the period in which the product remains on the market; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) easily and directly accessible, free of charge, through all major operating systems and browsers, without a need to register in advance, to download or install applications or to provide a password, and accessible to all potential users in the Union and competent authorities for control; | (b) easily and directly accessible, free of charge, through all major operating systems and browsers, without a need to register in advance, to download or install applications or to provide a password, and accessible to all users in the Union and competent authorities for control; |
The digital label, like the physical label, should be destined to all users of the feed additives or premixtures. The inclusion of the term "potential" introduces ambiguity and may give rise to differing interpretations.
| Text proposed by the Commission | Amendment |
|---|---|
| (b) easily and directly accessible, free of charge, through all major operating systems and browsers, without a need to register in advance, to download or install applications or to provide a password, and accessible to all potential users in the Union and competent authorities for control; | (b) easily and directly accessible, free of charge, through all major operating systems and browsers, without a need to register in advance, to download or install applications or to provide a password, and accessible to all users in the Union and competent authorities for control; |
The word ‘potential’ serves no discernible purpose and is, therefore, a source of unnecessary uncertainty and administrative burden.
| Text proposed by the Commission | Amendment |
|---|---|
| (c) made available for a period of two years from the date that the additive or premixture was placed on the market, including in the event of the insolvency, liquidation or cessation of activity in the Union of the economic operator that created it. | (c) made available for a period of five years from the date that the additive or premixture was placed on the market, including in the event of the insolvency, liquidation or cessation of activity in the Union of the economic operator that created it. |
| Text proposed by the Commission | Amendment |
|---|---|
| 9. The Commission is empowered to adopt delegated acts in accordance with Article 21a in order to supplement this Regulation by establishing rules to enhance and facilitate labelling by the use of digital means. Those rules may relate in particular to the nature of the information concerned, which may include information referred to in paragraphs 2, 4 and 5, or the type of digital means that may be used. Safety-critical and essential-use information, such as that included in the authorisation, shall remain on the label attached to the packaging or container referred to in paragraph 2.; | 9. The Commission is empowered to adopt delegated acts in accordance with Article 21a in order to supplement this Regulation by establishing rules to enhance and facilitate labelling by the use of digital means. Those rules may relate in particular to the nature of the information concerned, which may include information referred to in paragraphs 2, 4 and 5, or the type of digital means that may be used. Digital means shall only complement the information provided on the label and shall not replace information necessary for the safe use, handling, traceability or control of feed additives and premixtures. Such information shall include, in particular, conditions of use, warnings, restrictions of use, target animal species or categories, maximum authorised levels, incompatibilities, precautions for handling and any other requirements laid down in the authorisation necessary to ensure the safe use of the additive or premixture.; |
Carmen Crespo Díaz, Esther Herranz García, Dolors Montserrat, Juan Ignacio Zoido Álvarez, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| 9. The Commission is empowered to adopt delegated acts in accordance with Article 21a in order to supplement this Regulation by establishing rules to enhance and facilitate labelling by the use of digital means. Those rules may relate in particular to the nature of the information concerned, which may include information referred to in paragraphs 2, 4 and 5, or the type of digital means that may be used. Safety-critical and essential-use information, such as that included in the authorisation, shall remain on the label attached to the packaging or container referred to in paragraph 2. | 9. The Commission is empowered to adopt delegated acts in accordance with Article 21a in order to supplement this Regulation by establishing rules to enhance and facilitate labelling by the use of digital means. Those rules may relate in particular to the nature of the information concerned, which may include information referred to in paragraphs 2, 4 and 5, or the type of digital means that may be used. Safety-critical and essential-use information, such as that included in the authorisation, shall remain on the label attached to the packaging or container referred to in paragraph 2. Any other information which is not safety critical or essential for the correct use of the additive or premixture may also be provided by digital means, provided that there is a guarantee of free, direct, permanent and intelligible access for professional users and competent authorities. |
| Text proposed by the Commission | Amendment |
|---|---|
| (10a) In Article 25, a new paragraph 2a is added: | |
| 2a. Applications for renewal of an authorisation under Article 14, duly submitted before [the date of entry into force of the Regulation], and not yet decided on at that date shall be further processed in accordance with the provisions introduced by the amending Regulation. | |
| Insofar as the feed additive concerned is no longer subject to an obligation to renew under the amended provisions, the pending renewal procedure shall be deemed to have been completed. The existing authorisation shall continue to apply under the existing conditions, unless there are specific and substantiated safety concerns. Where there is a substantiated indication of a security risk, the Commission may request additional information on a case-by-case basis and take the necessary measures in accordance with Article 13. |
| Present text | Amendment |
|---|---|
| (10a) In Annex III, point 1, the following new introductory part is inserted: | |
| ANNEX III | "ANNEX III |
| 1. SPECIFIC LABELLING REQUIREMENTS FOR CERTAIN FEED ADDITIVES AND FOR PREMIXTURES | 1. SPECIFIC LABELLING REQUIREMENTS FOR CERTAIN FEED ADDITIVES AND FOR PREMIXTURES |
| Where information referred to in this Annex is already mandatorily displayed on the label or in the accompanying documents pursuant to Regulation (EC) No 767/2009, a duplicate information referred to in this Annex may be omitted, provided that the information is clearly identifiable, easily accessible and equivalent.” |
| Text proposed by the Commission | Amendment |
|---|---|
| (1a) A new Article 4a is inserted: | |
| "4a Digital procedures and standard templates for mobile slaughter operations | |
| 1. For activities referred to in Annex III, Section I, including mobile slaughter operations, Member States shall ensure that notifications, registrations and the transmission of the required information to the competent authority are facilitated in digital form via national systems. | |
| 2. The national systems shall be interoperable and shall allow for the use of Union-wide harmonised data sets and standard templates, without prejudice to national competences. | |
| 3. The Commission shall provide standard templates and harmonised minimum data sets, in particular for | |
| a) notifications and/or advance notices; | |
| b) process and hygiene checklists (including transport and temperature records); | |
| c) traceability and delivery documents. | |
| 4. The use of these templates shall give rise to a presumption that the relevant documentation requirements under this Regulation have been met, without prejudice to risk-based official controls." |
| Present text | Amendment |
|---|---|
| In Annex III, Section I, Chapter VIa, point (c) is amended as follows: | |
| (c) the slaughterhouse or the owner of the animals intended for slaughter must inform the official veterinarian at least three days in advance of the date and time of intended slaughter of the animals; | (c) the slaughterhouse or the owner of the animals intended for slaughter must inform the official veterinarian at least three days in advance of the date and time of intended slaughter of the animals. For recurrent slaughter at the holding of origin, the competent authority may provide for a framework approval. In this case, the notification referred to in the first sentence may be provided by means of time-frame or collective notifications through national digital systems, provided that the minimum information required for official controls is available for each slaughter (in particular, the date and number of farm animals to be slaughtered in the intended slaughter); |
| Present text | Amendment |
|---|---|
| In Annex III, Section I, the following Chapter VIab (new) is added: | |
| ‘CHAPTER VIab: MOBILE SLAUGHTER (MOBILE SLAUGHTERHOUSE) | |
| A mobile slaughterhouse may be approved as a slaughterhouse provided that it is designed, operated and maintained in such a way as to achieve the objectives of the hygiene requirements laid down in this Regulation, in particular through: | |
| (a) the prevention of cross-contamination, | |
| (b) appropriate facilities and procedures for cleaning and disinfection, | |
| (c) the availability of water of an appropriate hygiene standard; | |
| (d) the safe collection, separation and handling of animal by-products; | |
| (e) appropriate measures to control the temperature of carcasses and/or meat. | |
| By way of derogation from the structural requirements of stationary slaughterhouses, Member States may allow equivalent solutions for mobile slaughterhouses, provided that an equivalent level of risk control is ensured.’ |
| Present text | Amendment |
|---|---|
| – In Regulation (EC) No 1099/2099, Article 1, paragraph 1, the second subparagraph is deleted |
| Present text | Amendment |
|---|---|
| – In Regulation (EC) No 1099/2099, Article 1, paragraph 3 is deleted. |
| Present text | Amendment |
|---|---|
| – In Regulation (EC) No 1099/2099, Article 4, paragraph 4 is deleted. |
| Text proposed by the Commission | Amendment |
|---|---|
| In Regulation (EC) No 1099/2009 Article 18, paragraphs 4 and 6 are deleted. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| In Regulation (EC) No 1099/2009 Article 18, paragraphs 4 and 6 are deleted. | deleted |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Thomas Bajada, Mohammed Chahim
| Text proposed by the Commission | Amendment |
|---|---|
| In Regulation (EC) No 1099/2009 Article 18, paragraphs 4 and 6 are deleted. | In Regulation (EC) No 1099/2009, Article 18(4) and (6) are replaced by the following: |
| 4. By 30 June every second year, the competent authority referred to in paragraph 1 shall transmit to the Commission a report on the depopulation operations carried out during the preceding two calendar years and shall make that report publicly available. The report shall include, as a minimum: | |
| (a) the reasons for the depopulation; | |
| (b) the number and species of animals killed; | |
| (c) the stunning and killing methods used; | |
| (d) the number and type of derogations granted pursuant to paragraph 3; | |
| (e) any significant animal welfare incidents identified during depopulation operations and the corrective measures taken. |
The complete removal of reporting obligations on depopulation operations would reduce transparency and make it more difficult to monitor the implementation of Union animal welfare legislation. At the same time, annual reporting may create unnecessary administrative burden for competent authorities. A harmonised biennial reporting system focusing on a limited set of key indicators strikes a proportionate balance between reducing reporting obligations and maintaining effective oversight of depopulation practices, the use of derogations and animal welfare outcomes.
Biljana Borzan, Christophe Clergeau, Gheorghe Cârciu, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Thomas Bajada, Mohammed Chahim
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Commission may adopt implementing acts laying down a harmonised format for the reports referred to in paragraph 4 in order to ensure consistency, comparability and minimise the administrative burden. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 25(2). |
The complete removal of reporting obligations on depopulation operations would reduce transparency and make it more difficult to monitor the implementation of Union animal welfare legislation. At the same time, annual reporting may create unnecessary administrative burden for competent authorities. A harmonised biennial reporting system focusing on a limited set of key indicators strikes a proportionate balance between reducing reporting obligations and maintaining effective oversight of depopulation practices, the use of derogations and animal welfare outcomes.
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall within 12 months of the entry into force of this Regulation adopt an implementing act establishing a harmonised reporting template for depopulation operations to simplify data collection and to ensure that the information provided by Member States is complete, consistent, comparable and proportionate, taking into account the administrative burden of Member States. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 10 | deleted |
| Amendment to Regulation (EC) No 999/2001 |
Biljana Borzan, Christophe Clergeau, Gheorghe Cârciu, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission is empowered to adopt delegated acts in accordance with Article 23b for the purpose of approval of the rapid tests and to amend the list set out in Annex X, Chapter C, point 4; | The Commission is empowered to adopt delegated acts in accordance with Article 23b for the purpose of approval of the rapid tests and to amend the list set out in Annex X, Chapter C, point 4, only if such acts are in line with the scientific advice of the relevant EFSA expert group; |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission is empowered to adopt delegated acts in accordance with Article 23b for the purpose of approval of the rapid tests . The Commission is empowered to adopt delegated acts in accordance with Article 23b amending Annex X to list those tests.; | The Commission is empowered to adopt delegated acts in accordance with Article 23b for the purpose of approval of the rapid tests . The Commission is empowered to adopt delegated acts in accordance with Article 23b amending Annex X to list those tests, only if such acts are in line with the scientific advice of the relevant EFSA expert group.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The annual monitoring programme referred to in paragraph 1 shall cover the animal subpopulations listed in Annex III. The Commission is empowered to adopt delegated acts in accordance with Article 23b to amend the provisions of that paragraph according to scientific progress and after consultation of the European Food Safety Authority.; | 1a. The annual monitoring programme referred to in paragraph 1 shall cover the animal subpopulations listed in Annex III. The Commission is empowered to adopt delegated acts in accordance with Article 23b to amend the provisions of that paragraph according to scientific progress and after consultation of the European Food Safety Authority. Adaptations of age thresholds and bovine subpopulations shall not result in a reduction of surveillance sensitivity unless supported by an EFSA scientific opinion demonstrating that an equivalent level of protection of human and animal health is maintained.; |
Benoit Cassart, Christine Singer, Olivier Chastel, Asger Christensen, Ciaran Mullooly, Charles Goerens
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission is empowered to adopt delegated acts in accordance with Article 23b to amend the list of specified risk material referred to in Annex V . Taking into account the different risk categories laid down in the first subparagraph of Article 5(1) and the requirements of Article 6(1a) and (1b) (b) the list of specified risk material in Annex V shall be amended accordingly. | The Commission is empowered to adopt delegated acts in accordance with Article 23b to amend Annex V taking into account the latest scientific evidence and the evolution of the epidemiological situation. Taking into account the different risk categories laid down in the first subparagraph of Article 5(1) and the requirements of Article 6(1a) and (1b) (b) the list of specified risk material in Annex V shall be amended accordingly. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The power to adopt delegated acts referred to in Article 5(3), Article 6(1) and (1a), Article 8(1), (2), and (5), and Article 16(7) and Article 23 (3) shall be conferred for an indeterminate period of time from the date of the entry into force of this Regulation. | 2. The power to adopt delegated acts referred to in Article 5(3), Article 6(1) and (1a), Article 8(1), (2), and (5), and Article 16(7) and Article 23 (3) shall be conferred for an indeterminate period of time from the date of the entry into force of this Regulation. The Commission shall not adopt delegated acts pursuant to this Regulation that modify monitoring, surveillance, testing or risk-mitigation measures unless the Commission demonstrates, on the basis of the latest relevant scientific advice of the European Food Safety Authority (EFSA), that such modifications maintain or improve the level of protection of animal and public health provided for under this Regulation. |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The power to adopt delegated acts referred to in Article 5(3), Article 6(1) and (1a), Article 8(1), (2), and (5), and Article 16(7) and Article 23 (3) shall be conferred for an indeterminate period of time from the date of the entry into force of this Regulation. | 2. The power to adopt delegated acts referred to in Article 5(3), Article 6(1) and (1a), Article 8(1), (2), and (5), and Article 16(7) and Article 23 (3) shall be conferred for an indeterminate period of time from the date of the entry into force of this Regulation. Given the sensitivity of the matter at hand, the delegation of powers shall be based on the condition that the Commission’s proposed delegated acts are in line with the scientific advice of the relevant EFSA expert group. |
| Present text | Amendment |
|---|---|
| (-1a) In Article 9, paragraph 4, new subparagraphs 1a and 1b are added: | |
| “The competent authorities shall ensure that overlapping and duplicate controls are avoided when planning and carrying such activities. Where possible, controls relating to the same establishment, the same activities and the same risk area shall be combined into a single coordinated control visit (‘single inspection’), including coordinated sampling. | |
| Inspection results, test reports and sampling data collected in accordance with other relevant Union legislation shall be recognised and reused, provided that the scope, timeliness and quality of the inspections are equivalent. Additional inspections of the same subject matter shall only be carried out if indicated for specific risk-based reasons.” |
| Present text | Amendment |
|---|---|
| (-1b) In Article 13, paragraph 4 a new subparagraph 1a is added: | |
| “The competent authorities shall ensure that information and evidence lawfully obtained in the course of official controls is requested only once within the relevant system and will subsequently be reused for further relevant control purposes, provided that there are no changes in circumstances or new risk-based grounds.” |
| Present text | Amendment |
|---|---|
| (-1c) In Article 12, paragraph 3, a new point (ba) is added: | |
| “(ba) ensure that the documented control procedures include integrated control plans for establishments where requirements from several regulatory areas are to be checked simultaneously. These plans shall set out minimum standards for common checklists, coordinated sampling and the coordinated use of control data within and between the authorities involved.” |
| Present text | Amendment |
|---|---|
| (-1a) In Article 14, a new subparagraph 1a is added: | |
| “For the purpose of paragraph 1, letter h, mandatory analyses carried out in accordance with EU legislation on plant health are the responsibility of the Member State, including when these analyses are to be carried out on plants located on a site managed by a professional operator subject.” |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Present text | Amendment |
|---|---|
| (-1a) In article 14, point h is replaced by the following: | |
| sampling, analysis, diagnosis and tests. | "sampling, analysis, diagnosis and tests. Mandatory analyses carried out in accordance with EU legislation on plant health are the responsibility of the Member State, including when these analyses are to be carried out on plants located on a site managed by a professional operator subject" |
Biljana Borzan, Christophe Clergeau, Gheorghe Cârciu, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim
| Text proposed by the Commission | Amendment |
|---|---|
| iia. the competent authority has verified that the absence of accreditation for the method concerned does not compromise the reliability, quality, comparability or scientific validity of the results produced by the laboratory. |
Greater flexibility in the accreditation requirements for official laboratories should not reduce the reliability or scientific quality of official controls. Competent authorities should verify that any derogation from full accreditation does not compromise the quality or comparability of analytical results.
| Text proposed by the Commission | Amendment |
|---|---|
| Official control laboratories may hold a flexible accreditation, allowing the incorporation of new methods based on a technology or measurement principle that has already been accredited |
The term "flexible accreditation" is the official accreditation terminology used in the mandatory EA-2/15 document of the European co-operation for Accreditation (EA). It refers to "flexibility with regard to the introduction of new methods based on an already accredited measurement principle (technology)", a concept that is internationally recognised.
| Text proposed by the Commission | Amendment |
|---|---|
| (1a) the following Article 47a is added: | |
| Article 47a Conditions applicable to food of animal origin in relation to certain production and processing methods prohibited in the Union 1. | |
| Food of animal origin imported into the Union shall be placed on the market only if it comes from: | |
| (a) animals which have not been treated, at any stage of their rearing, with substances whose use is prohibited in the Union for reasons relating to the protection of human or animal health or to animal welfare requirements; | |
| (b) slaughtered animals and meat or carcasses which have not been treated with substances, nor undergone processing processes, that are prohibited in the Union for health or consumer protection reasons. | |
| 2. The requirements laid down in paragraph 1 shall apply irrespective of whether or not there are detectable residues of the substances or processes concerned in the final food products. | |
| 3. The substances and processes referred to in paragraph 1 shall include: | |
| (a) substances having a hormonal action whose use to stimulate growth is prohibited in the Union; | |
| (b) antimicrobial substances used as growth promoters; | |
| (c) chemical substances or processes which are applied to carcasses or meat and whose use is prohibited in the Union, including when used for microbiological decontamination. | |
| 4. Exporting third countries shall provide appropriate and verifiable guarantees of compliance with the requirements laid down in this Article, in particular by means of: | |
| (a) rules on farming, slaughter and carcass processing methods that are equivalent to the rules applicable in the Union; | |
| (b) traceability systems covering the entire production and processing chain; | |
| (c) schemes for the official certification of establishments and consignments intended for export to the Union. | |
| In order to verify compliance with those requirements, the Commission shall, as part of the Union activities provided for in this Regulation, carry out checks, audits and inspections, including in third countries, covering, inter alia, monitoring systems, competent authorities, rearing establishments, slaughterhouses and carcass processing plants. | |
| Where such checks are not carried out or appear to be insufficient, Member States may, in accordance with their powers under this Regulation, take appropriate action to verify compliance with those requirements, in particular when food products are brought into the Union. | |
| 5. Where it is found that the guarantees provided by a third country are insufficient or that there is a lack of compliance with the requirements laid down in this Article, the Commission shall adopt, in accordance with this Regulation, appropriate, proportionate and graduated measures, which may include stepping up official controls on imports and restricting or suspending imports of the food products concerned from all or part of the third country, region or establishments in question. | |
| The Commission shall adopt implementing acts specifying the list of substances and processes covered by this Article, the details of the guarantees and certifications required, and the criteria and practical arrangements for adopting, reviewing and lifting the measures provided for in this paragraph. |
The European Union prohibits the use of certain substances and processes in animal husbandry due to their adverse effects on human health, animal health, animal welfare and consumer protection. However, food of animal origin produced using methods prohibited in the EU can still access the EU market when imported from third countries. This amendment seeks to remedy that situation by establishing equivalence in the production and processing methods of food of animal origin.
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Consignments shall not be split until official controls have been performed and the Common Health Entry Document (CHED) referred to in Article 56 has been finalised in accordance with Article 56(5) and Article 57, unless requested by the competent authorities in the case of consignments of goods referred to in Article 47(1)(c) for the purposes of performing physical checks on only part of a consignment presented at a border control post.; | 3. Consignments shall not be split until official controls have been completed for the relevant part of the consignment and the Common Health Entry Document (CHED) referred to in Article 56 has been finalised with a favourable outcome in accordance with Article 56(5) and Article 57, unless requested by the competent authorities in the case of consignments of goods referred to in Article 47(1)(c) for the purposes of performing physical checks on only part of a consignment presented at a border control post. No part of the consignment shall be released for free circulation unless these requirements have been fulfilled for that specific part.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Consignments shall not be split until official controls have been performed and the Common Health Entry Document (CHED) referred to in Article 56 has been finalised in accordance with Article 56(5) and Article 57, unless requested by the competent authorities in the case of consignments of goods referred to in Article 47(1)(c) for the purposes of performing physical checks on only part of a consignment presented at a border control post.; | 3. Consignments shall not be split until official controls have been performed and the Common Health Entry Document (CHED) referred to in Article 56 has been finalised in accordance with Article 56(5) and Article 57. However, in the case of consignments of plants, plant products and other objects referred to in Article 47(1), points (c), (e) and (f) and/or in Article 44 (1), competent authorities may request a split if the physical checks on parts of the consignment require more time than those on the remaining part, allowing for the release of that remaining part for which official controls have been completed; |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Consignments shall not be split until official controls have been performed and the Common Health Entry Document (CHED) referred to in Article 56 has been finalised in accordance with Article 56(5) and Article 57, unless requested by the competent authorities in the case of consignments of goods referred to in Article 47(1)(c) for the purposes of performing physical checks on only part of a consignment presented at a border control post.; | 3. Consignments shall not be split until official controls have been performed and the Common Health Entry Document (CHED) referred to in Article 56 has been finalised in accordance with Article 56(5) and Article 57, unless requested by the competent authorities in the case of consignments of goods referred to in Article 47(1)(c) for the purposes of performing physical checks on only part of a consignment presented at a border control post, provided that such splitting does not compromise the traceability, integrity or effectiveness of official controls.; |
Allowing consignments to be split before the completion of official controls may improve operational efficiency. However, such flexibility should not compromise the traceability of consignments or the effectiveness and integrity of official controls.
| Text proposed by the Commission | Amendment |
|---|---|
| (2a) In Article 54, a new paragraph 2a is inserted: | |
| “2a. By way of derogation from the risk criteria referred to in paragraph 2, the minimum frequency of physical checks on consignments of animals and goods referred to in Article 47(1) shall be set at 30%. |
(2a) A minimum frequency of 30% for physical checks is necessary to ensure effective enforcement of Union sanitary and phytosanitary rules, combat illegal trade and fraud, and maintain a consistent level of food safety and public health across all Union entry points.(2b) This derogation ensures a proportionate, risk-based approach by avoiding unnecessary burdens on trade and logistics for products with a proven record of safety, while preserving a high level of protection.
| Text proposed by the Commission | Amendment |
|---|---|
| (2b) In Article 54, a new paragraph 2b is inserted: | |
| “2b. The Commission may, by means of implementing acts, establish a frequency lower than 30% for specific categories of goods identified as low risk. Such derogation shall be granted only where the following conditions are fulfilled: | |
| (a) a documented history of full compliance of the third country of origin for at least three years; | |
| (b) control systems in the third country assessed as equivalent to those of the Union; | |
| (c) absence of notifications in the Rapid Alert System for Food and Feed (RASFF) in the preceding 24 months.” |
(2a) A minimum frequency of 30% for physical checks is necessary to ensure effective enforcement of Union sanitary and phytosanitary rules, combat illegal trade and fraud, and maintain a consistent level of food safety and public health across all Union entry points.(2b) This derogation ensures a proportionate, risk-based approach by avoiding unnecessary burdens on trade and logistics for products with a proven record of safety, while preserving a high level of protection.
| Text proposed by the Commission | Amendment |
|---|---|
| (2a) in Article 54, a new paragraph 2a is inserted: | |
| '2a. The minimum frequency of physical checks on consignments of animals and goods referred to in Article 47(1) shall be set at 30%. | |
| The Commission may adopt implementing acts establishing a list of categories of goods identified as low risk for which a frequency of physical checks lower than 30% applies. Such derogation shall be granted only where the following conditions are fulfilled: | |
| (a) a documented history of full compliance of the third country of origin for at least three years; | |
| (b) control systems in the third country assessed as equivalent to those of the Union; | |
| (c) absence of notifications in the Rapid Alert System for Food and Feed (RASFF) in the preceding 24 months.' |
| Text proposed by the Commission | Amendment |
|---|---|
| (2a) in Article 54, the following paragraph is inserted: | |
| ‘2a. When determining the frequency of the identity checks and physical checks provided for in this Article, the Commission shall take into account, in its risk analysis, evidence of residues, in agricultural products imported from third countries, of active substances not approved in the Union. That analysis shall also take into account products that are in direct competition with Union agricultural products subject to specific phytosanitary constraints, in particular those of the outermost regions referred to in Article 349 of the Treaty on the Functioning of the European Union.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (2a) in Article 54, a new paragraph 2a is inserted: | |
| "2a. When determining the frequency of identity checks and physical checks provided for in this Article, the Commission shall take into account, in its risk analysis, indications of the presence of residues of active substances not approved in the Union in agricultural products imported from third countries. That analysis shall also take into consideration products competing directly with agricultural production in the Union that is subject to specific phytosanitary constraints, in particular production in the Outermost Regions referred to in Article 349 of the Treaty on the Functioning of the European Union." |
| Text proposed by the Commission | Amendment |
|---|---|
| (2a) in Article 54, a new paragraph 2b is inserted: | |
| "2a. The Commission may, by means of implementing acts, establish a frequency lower than 30% for specific categories of goods identified as low risk. Such derogation shall be granted only where the following conditions are fulfilled: | |
| (a) a documented history of full compliance of the third country of origin for at least three years; | |
| (b) control systems in the third country assessed as equivalent to those of the Union; | |
| (c) absence of notifications in the Rapid Alert System for Food and Feed (RASFF) in the preceding 24 months." |
The introduction of this derogation is consistent with the principle of proportionality and avoids placing an unnecessary burden on port and airport logistics or disrupting international trade in goods with a well-established record of safe use. This approach could also facilitate agreement during negotiations with the Commission and the European Parliament on a minimum inspection rate of 30%.
| Text proposed by the Commission | Amendment |
|---|---|
| (2a) in Article 54, a new paragraph 2a is inserted: | |
| "2a. By way of derogation from the risk criteria referred to in paragraph 2, the minimum frequency of physical checks on consignments of animals and goods referred to in Article 47(1) shall be set at 30%." |
Increase in the frequency of physical checks: in order to effectively monitor compliance with Union sanitary and phytosanitary rules, to reduce illegal trafficking of goods, smuggling and fiscal and customs fraud, and to ensure a uniform level of food safety and public health for consumers at all points of entry into the Union, it is necessary to introduce a mandatory minimum threshold of 30% for physical checks on consignments. This threshold ensures that control pressure remains effective even where risk assessments are favourable, thereby preventing the entry of non-compliant goods due to statistical fluctuations or shortcomings in oversight by third countries.
| Text proposed by the Commission | Amendment |
|---|---|
| (2b) in Article 54, a new paragraph 2b is inserted: | |
| "2b. The Commission may, by means of implementing acts, establish a frequency lower than 30% for specific categories of goods identified as low risk. Such derogation shall be granted only where the following conditions are fulfilled: (a) a documented history of full compliance of the third country of origin for at least three years; (b) control systems in the third country assessed as equivalent to those of the Union; (c) absence of notifications in the Rapid Alert System for Food and Feed (RASFF) in the preceding 24 months.” |
Specific derogation for low-risk products: the introduction of this derogation is consistent with the principle of proportionality and avoids overburdening port and airport logistics and disrupting international trade in goods with a proven record of safety. (Note: this may facilitate the establishment of a 30% minimum threshold for checks during negotiations with the Commission and the European Parliament.)
| Text proposed by the Commission | Amendment |
|---|---|
| (2b) in Article 56, a new paragraph 2b is inserted: | |
| "2b. For wood packaging material as referred to in Article 43(1) of Regulation (EU) No 2016/2031 and for each consignment of plants as referred to in the lists established pursuant to Article 73 of Regulation (EU) No 2016/2031, the competent authorities may request operators responsible for the consignment to complete the relevant part of the Common Health Entry Document (CHED), providing the information necessary for the immediate and complete identification of the consignment and its destination." |
| Text proposed by the Commission | Amendment |
|---|---|
| (4a) in Article 109, a new paragraph 2a is inserted: | |
| ‘2a. When establishing the coordinated control programmes referred to in this Article, the Commission shall take into account the specific characteristics of the outermost regions referred to in Article 349 of the Treaty on the Functioning of the European Union. In view of their geographical location, their specific climate and phytosanitary conditions, and their role as the Union’s first phytosanitary border for many pests, those programmes may include specific sampling plans, control priorities tailored to the risks identified in those regions, and enhanced cooperation between Union reference laboratories and the relevant laboratories in the outermost regions.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (4a) in Article 109, a new paragraph 2a is added: | |
| "2a. When establishing the coordinated control programmes referred to in this Article, the Commission shall take account of the specific characteristics of the Outermost Regions referred to in Article 349 of the Treaty on the Functioning of the European Union. In view of their geographical situation, their particular climatic and phytosanitary conditions, and their role as the Union’s first line of phytosanitary defence against numerous pests, those programmes may provide for specific sampling plans, control priorities tailored to the risks identified in those regions, and enhanced cooperation between the European Union reference laboratories and the competent laboratories of the Outermost Regions." |
| Present text | Amendment |
|---|---|
| (4a) in Article 113, paragraph 1, the introductory part is replaced by the following: | |
| 1. By 31 August every year, each Member State shall submit to the Commission a report setting out:(a)any amendments made to its MANCP to take account of the factors referred to in Article 111(2); | "1. By 31 August every year, each Member State shall publish and submit to the Commission a report setting out:(a)any amendments made to its MANCP to take account of the factors referred to in Article 111(2);" |
| Present text | Amendment |
|---|---|
| (4a) in Article 113, paragraph 1, a new point ea is added: | |
| “(ea) the depopulation operations carried out during the previous year. For each depopulation operation, the following information shall be indicated: | |
| - the reasons that led to the depopulation; | |
| - the number of animals killed and the species concerned; | |
| - the stunning and killing methods used; | |
| - the difficulties encountered during the operation; | |
| - the solutions adopted to mitigate or minimise the suffering of the animals concerned. | |
| Where derogations are granted in accordance with Article 18(3) of Regulation (EC) No 1099/2009, such derogations shall also be mentioned.” |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 11a | |
| Article 11a - Amendment to Regulation 1925/2006 | |
| Regulation 1925/2006 is amended as follows: | |
| In article 8, after paragraph 1, paragraph 1a is added | |
| 1a. The provision of paragraph 1 shall be limited to the evaluation of purified substances intentionally added to food, and not to foods or food ingredients naturally containing such substances. |
Article 8 of Regulation (EC) No 1925/2006 should apply only to purified substances intentionally added to food, not to complex natural matrices. This approach is supported by the Judgment of the General Court (Case T-302/21), which annulled entries introduced under Regulation (EU) 2021/468. It is also justified legally and scientifically, as EFSA’s methodology is not suited for natural matrices. A broader application could unjustifiably restrict traditional foods and innovation without additional public health benefits.
| Text proposed by the Commission | Amendment |
|---|---|
| Article 11a | |
| Amendment to Commission Regulation 2023/915 | |
| (1) Article 10 is amended as follows: | |
| (a) in Article10, a new paragraph 2a is inserted: | |
| 2a. | |
| Where it is necessary in order to allow for the normal marketing, processing and consumption of products, the regulations setting or modifying maximum levels of contaminants set out in Annex I shall establish transitional measures allowing for the placing or remaining on the market in the Union of products that, at the time of their placing on the market or at the time of their placing into storage after production, were compliant with the maximum contaminant levels applicable or to which no maximum contaminant level was applicable, at least until the date of minimum durability. | |
| (b) in Article 10, a new paragraph 2b is inserted: | |
| 2b. | |
| Paragraph 2(a) applies to products whose ingredients within the meaning of Regulation (EU) No 1169/2011 at the time of these ingredients’ placing on the market or at the time of their placing into storage after production were compliant with the maximum contaminant levels applicable or to which no maximum contaminant level was applicable. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 11a | |
| The Commission shall, no later than five years after the entry into force of Regulation (EU) .../... [the Food and Feed Simplification Regulation], publish a report assessing the impact of the measures introduced by that Regulation on the efficiency and duration of the approval and authorisation procedures for active substances and plant protection products. The report shall identify any remaining regulatory bottlenecks and, where appropriate, be accompanied by recommendations for further measures to accelerate access to safe and effective crop protection solutions. |
While the proposal introduces several measures intended to accelerate the approval process for active substances, it remains uncertain whether these changes will effectively reduce approval timelines in practice. A review after five years would provide an evidence-based assessment of the Regulation's impact and help identify any remaining bottlenecks in the approval process.
| Text proposed by the Commission | Amendment |
|---|---|
| Article 11a | |
| Report | |
| The Commission shall, no later than five years after the entry into force of this Regulation, publish a report assessing the impact of the measures introduced by this Regulation on the efficiency and duration of the approval and authorisation procedures for active substances and plant protection products. The report shall identify any remaining regulatory bottlenecks and, where appropriate, be accompanied by recommendations for further measures to accelerate access to safe and effective crop protection solutions. |
While the proposal introduces several measures intended to accelerate the approval process for active substances, it remains uncertain whether these changes will effectively reduce approval timelines in practice. A review after five years would provide an evidence-based assessment of the Regulation’s impact and help identify any remaining bottlenecks in the approval process.
| Text proposed by the Commission | Amendment |
|---|---|
| Article 11a | |
| No later than 12 months after the entry into force of this Regulation, the Commission shall assess whether further legislative measures are necessary to improve coherence between the Union legislative framework on food and feed safety, transmissible spongiform encephalopathies, animal by-products and EU fertilising products, with particular attention being paid to removing unnecessary regulatory fragmentation that impedes the safe circular use of nutrients and materials of animal origin. In that assessment, the Commission shall take into account in particular the availability and affordability of fertilisers and nutrients as an essential prerequisite for agricultural production and food security in the Union. Where the Commission identifies inconsistencies or obstacles, it shall submit a legislative proposal to remove them, whilst maintaining a high level of protection for human and animal health. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 11b | |
| No later than five years after the entry into force of this Regulation, the Commission shall publish a report assessing the impact of the measures introduced by this Regulation on the efficiency and duration of the procedures for the approval of active substances and the authorisation of plant protection products. The report shall identify any remaining regulatory bottlenecks and, where appropriate, be accompanied by recommendations for further measures to accelerate access to safe and effective plant protection solutions. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 11b | |
| No later than one year after the entry into force of this Regulation, and every three years thereafter, the Commission shall publish a report assessing: | |
| (a) active substances and plant protection products that are expected to lose their approval the within the following five years; | |
| (b) the potential consequences for crop protection, including impacts on specific crops, pest and disease management and agricultural productivity; | |
| (c) the availability and effectiveness of alternative solutions, including biological control, low-risk substances, resistant varieties, plant breeding innovations, precision agriculture and mechanical or other non-chemical techniques. | |
| Where the report identifies significant crop protection gaps for which no adequate alternatives are available, the Commission shall take appropriate measures to facilitate the development and availability of solutions. These measures may include prioritising the assessment of relevant applications, promoting research and innovation, and supporting the development of alternative crop protection approaches. |
Farmers increasingly face the loss of active substances while effective alternatives are not always available in time. This may result in significant crop protection gaps and jeopardise agricultural production and competitiveness. An early assessment of future bottlenecks is therefore needed, together with a structured approach to prioritise assessments and stimulate research and innovation where no adequate solutions exist. Alternative solutions should also include plant breeding, precision agriculture, biological control and other innovative crop protection techniques.
Connections
The dossier, the decisions on this text and its other versions.
No connections found for this item.
Sources & citation
Where the facts on this page come from, and how to cite it.
- Data source
- Licensed CC BY 4.0.
- Retrieved
- 25 September 2026
Cite as
European Parliament (2026). “AMENDMENTS 1337 - 1488 - Draft report on the proposal for a regulation of the European Parliament and of the Council Amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements”. Text, 28 July 2026. docId CJ14-AM-791052. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/CJ14-AM-791052 (retrieved 25 September 2026). Data: EP Open Data API: document record, https://data.europarl.europa.eu/api/v2/documents/CJ14-AM-791052 (CC BY 4.0).
BibTeX
@misc{epw-text-cj14-am-791052,
author = {{European Parliament}},
title = {{AMENDMENTS 1337 - 1488 - Draft report on the proposal for a regulation of the European Parliament and of the Council Amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements}},
year = {2026},
date = {2026-07-28},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/CJ14-AM-791052}},
url = {https://news.eu-parl.st-solutions.dev/texts/CJ14-AM-791052},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Text. docId CJ14-AM-791052. Data: EP Open Data API: document record (CC BY 4.0)}
}