Changes from adopted text to adopted text

Removed(2) in paragraph 3, point (b) is replaced by the following:

Removed‘(b) the cultivation of GMOs for food and feed production and the correct application of the plan for monitoring referred to in Article 13(2), point (e), of Directive 2001/18/EC, in Article 5(5), point (b), and Article 17(5), point (b), of Regulation (EC) No 1829/2003 and in Articles 14(1), point (h) and 19(3), point (b) of Regulation [reference to this Regulation];.’

RemovedArticle 33a Amendments to Directive 98/44/EC

Removed1. Article 4 of Directive 98/44/EC on the legal protection of biotechnological inventions is amended as follows:

Removed(a) In paragraph 1, the following points are added:

Removed‘(c) NGT plants, plant material, parts thereof, genetic information and process features they contain, as defined in Regulation (EU) .../... [O.J. please insert the number of this Regulation];

Removed(d) plants, plant material, parts thereof, genetic information and process features they contain that can be yielded by techniques excluded from the scope of Directive 2001/18/EC as listed in Annex I B to that directive.’

Removed(b) the following paragraph 4 is added:

Removed‘4. Paragraphs 2 and 3 shall be without prejudice to the exclusions from patentability covered in paragraph 1.’

Removed2. In Article 8, the following paragraph is added:

Removed‘3. By way of derogation from paragraphs 1 and 2, the protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention shall not extend to biological material possessing the same characteristics that is obtained independently of the patented biological material and from essentially biological processes, or to biological material obtained from such material through propagation or multiplication.’

Removed3. In Article 9, the following paragraphs are added:

Removed‘2. By way of derogation from paragraph 1, a plant product containing or consisting of genetic information obtained by a patentable technical process shall not be patentable if it is not distinguishable from plant products containing or consisting of the same genetic information obtained by an essentially biological process.

Removed3. By way of derogation from paragraph 1, the protection conferred by a patent on a product containing or consisting of genetic information shall not extend to plant material in which the product is incorporated and in which the genetic information is contained and performs its function but which is not distinguishable from plant material obtained or which can be obtained by an essentially biological process.

Removed4. The protection conferred by a patent on a technical process that enables the production of a product containing or consisting of genetic information shall not extend to plant material in which the product is incorporated and in which the genetic information is contained and performs its function but which is not distinguishable from plant material obtained or which can be obtained by an essentially biological process.’ [Ams. 69, 291cp1, 230/rev1 and 291cp3]

RemovedArticle 34 Entry into force and application

Removed1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Removed2. It shall apply from [24 months from the date of entry into force of this Regulation]. Article 4a and Article 33a shall apply from the date of entry into force. [Am. 70]

RemovedThis Regulation shall be binding in its entirety and directly applicable in all Member States.

RemovedDone at …,

RemovedFor the European Parliament For the Council

RemovedThe President The President

RemovedAnnex I

RemovedCriteria of equivalence of NGT plants to conventional plants

RemovedA NGT plant is considered equivalent to conventional plants when it differs from the recipient/parental plant by no more than 20 genetic modifications of the typesif the following conditions referred to in points 1 to 5, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools.and 1a are met: [Am. 71]

Removed(1) The number of the following genetic modifications, which can be combined with each other, does not exceed 3 per any protein-coding sequence taking into account that mutations in introns and regulatory sequences are excluded from this limit:

Removed(a) substitution or insertion of no more than 20 nucleotides;

Removed(b) deletion of any number of nucleotides; [Am. 72]

Removed(1a) The following genetic modifications, which can be combined with each other, do not create a chimeric protein that is not present in species from the gene pool for breeding purposes or does not interrupt an endogenous gene;

Removed(a) insertion of continuous DNA sequences existing in the gene pool for breeding purposes;

Removed(b) substitution of endogenous DNA sequences with continuous DNA sequences existing in the gene pool for breeding purposes;

Removed(c) inversion or translocation of continuous endogenous DNA sequences existing in the gene pool for breeding purposes. [Am. 73]

Removed(2) deletion of any number of nucleotides; [Am. 74]

Removed(3) on the condition that the genetic modification does not interrupt an endogenous gene:

Removed(a) targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool;

Removed(b) targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s gene pool; [Am. 75]

Removed(4) targeted inversion of a sequence of any number of nucleotides; [Am. 76]

Removed(5) any other targeted modification of any size, on the condition that the resulting DNA sequences already occur (possibly with modifications as accepted under points (1) and/or (2)) in a species from the breeders’ gene pool. [Am. 77]

RemovedAnnex II

RemovedRisk assessment of category 2 NGT plants and category 2 NGT food and feed

RemovedPart 1 of this Annex describes the general principles to be followed to perform the environmental risk assessment of category 2 NGT plants referred to in Article 13, points (c) and (d), Article 14(1), point (e), and Article 19(3), point (a), and the safety assessment of category 2 NGT food and feed referred to in Article 19(1), point (b). Part 2 describes specific information for the environmental risk assessment of category 2 NGT plants and Part 3 describes specific information for the safety assessment of category 2 NGT food and feed.

RemovedPart 1- General principles and information

RemovedThe environmental risk assessment shall be carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC.

RemovedThe type and amount of information necessary for the environmental risk assessment of category 2 NGT plants laid down in Annex III of Directive 2001/18/EC and for the food and feed safety assessment of category 2 NGT food and feed shall be adapted to their risk profile. Factors to be considered include:

Removed(a) the characteristics of the NGT plant, in particular the trait(s) introduced, the function of the modified or inserted genome sequence(s) and the function of any gene disrupted by the insertion of a cisgene or parts thereof;

Removed(aa) the characteristics of the recipient plant like allergenicity, potential for gene flow, weed potential, ecological function; [Am. 78]

Removed(b) prior experience with the consumption of similar plants or their products;

Removed(c) prior experience with the cultivation of the same plant species or plant species exhibiting similar traits or in which similar genome sequences have been modified, inserted or disrupted;

Removed(d) the scale and conditions of the release;

Removed(e) the intended conditions of use of the NGT plant.

RemovedThe environmental risk assessment of category 2 NGT plants and the risk assessment of category 2 NGT food and NGT feed shall consist of the following:

Removed(a) hazard identification and characterisation;

Removed(b) exposure assessment;

Removed(c) risk characterisation.

RemovedThe following information shall always be required:

Removed(a) hazard identification and characterisation

Removed(i) information relating to the recipient plant or, where appropriate, to the parental plants;

Removed(ii) molecular characterisation.

RemovedThe information shall be provided by collating already available data from scientific literature or from other sources or generating scientific data where necessary by performing appropriate experimental or bioinformatic studies.

Removed(b) exposure assessment