Changes from report parliamentary committee draft to plenary report

Change 1

AddedRecital 8: (8) Correspondingly, this Regulation aims to address the eventual divergence between scientific opinions of the European Food Safety Authority and those of other Union agencies. Regulation (EC) No 178/2002 of the European Parliament and Council already contains provisions establishing a procedure to solve divergent scientific opinions. Those resolution procedures should be reinforced, in that the European Food Safety Authority and the other dissenting agency should be bound to make their best effort to resolve the divergence on general scientific issues. Differences in assessment methodologies resulting in divergent opinions, particularly with regard to the protection of vulnerable groups, should be duly justified. In such instances, priority should be given to the most protective opinion to safeguard vulnerable groups. Only when they are not able to resolve the divergence, should they refer to risk managers.

AddedRecital 9: (9) In the more specific case of scientific divergence pertaining to the hazard identification of chemical substances, a new procedure enabling the resolution of the divergence should be established. This procedure should enable the Commission to request the European Chemicals Agency, as the Union agency most equipped with expertise and capacity in hazard assessment, as well as long-standing experience with the harmonised classification and labelling process, to develop a proposal for harmonised classification and labelling, in accordance with Regulation (EC) No 1272/2008 of the European Parliament and Council, moving closer to the ‘one substance, one assessment’ vision as regards uniformity of hazard assessments of chemicals across the Union, enhancing the protection of health and the environment. This possibility should be reflected in the relevant provision providing for the resolution of diverging scientific opinions laid down in Regulation (EC) No 178/2002.

AddedRecital 14 a (new): (14a) This Regulation expands the tasks, workload and remit of the scientific committees of the European Chemicals Agency. In order to provide adequate expertise, support and thorough scientific evaluations, appropriate and stable resources, capacity and governance of the scientific committees should be ensured. In this respect, the European Commission should regularly monitor the needs of the European Chemicals Agency stemming from this Regulation, and provide the Agency with sufficient and stable resources.

Change 2

ChangedArticle 1 – paragraph 1 – point 2, Article 30: 4. Where a substantive divergence30 over– scientificparagraph issues2 has– beensubparagraph identified1: andWhere the body in questionAuthority isidentifies a Memberpotential Statesource body,of thedivergence, Authorityit andshall thecontact nationalthe body shallconcerned bein obligedorder to cooperateensure withthat aall viewrelevant toscientific eitheror resolvingtechnical theinformation divergenceis orshared preparingand ain jointorder documentto clarifyingidentify the potentially contentious scientific issuesor andtechnical identifyingissues. theDifferences relevantin uncertaintiesassessment inmethodologies theresulting data.in Thisdivergent documentopinions shall be madeduly public.justified, especially regarding the protection of vulnerable groups.

Change 3

RemovedA clear incentive for all the bodies involved in the process to work towards resolving divergent views is still missing. Paragraph 4 (deleted in the new version by the Commission) is restored, in order to ensure that all the bodies involved in the process work together with a view to either resolving the divergence or preparing a joint document clarifying the contentious scientific issues. Plant protection products formulations are almost always manufactured for the common European market, not for individual Member states. This means divergence in opinions on co-formulants across Member states leads to fragmentation of the common market, single sourcing and supply chain risk.

Change 4

ChangedArticle 1 – paragraph 1 – point 2, Article 30 – paragraph 4 a (new): 4a. In cases2 where– asubparagraph divergence2: isThe identified,Authority and the Authoritybody requestsconcerned additionalshall informationcooperate fromto resolve the otherdivergence, Unionwith agenciesthe oraim bodies,of orensuring Memberthe Statehighest bodies,level theof periodprotection byof whenhealth and the relevantenvironment. authoritiesPriority areshall requiredbe togiven adoptto theirthe respectiveopinion output,that oraffords the jointhighest reportlevel referredof toprotection in paragraphorder 2to ofsafeguard thisthe Article,most shouldvulnerable begroups. sufficient.If Afterthe consultingAuthority and the body concerned,concerned are not able to resolve the Authoritydivergence, they shall laydraw downup a period withinjoint whichreport. thisThe informationreport shall beclearly providedoutline andthe shallcontentious informscientific issues, identify the Commissionrelevant ofuncertainties thein additionalthe perioddata needed.and Thethe Commissionpossible shallcauses informfor the concerneddiverging businessopinions, operator(s)including andon themethodological Memberdifferences, Statesand ofbe themade extension.publicly available.

Change 5

RemovedWhen it comes to procedures for authorisation of regulated products, specific legal deadlines apply. The difficulty resulted from this is how accommodate the necessary time for cooperation to resolve divergences within the specific deadlines given in the sectorial legislation. No time frame or allocation of extra time is prescribed for resolving divergences under Article 30(2). The proposed mechanism allows sufficient time to resolve this issues, and is inspired from Article 6 of Regulation 1331/2008.

AddedRegulation (EC) No 178/2002

AddedArticle 1 – paragraph 1 – point 2, Article 30 – paragraph 3 a (new): 3a. Where a substantive divergence over scientific issues has been identified and the body in question is a Member State body, the Authority and the national body shall be obliged to cooperate with a view to either resolving the divergence or preparing a joint document clarifying the contentious scientific issues and identifying the relevant uncertainties in the data. That document shall be made public.

AddedRegulation (EC) No 178/2002

AddedArticle 1 – paragraph 1 – point 2, Article 3 – paragraph 3 b (new): 3b. In cases where a divergence is identified, and the Authority requests additional information from the other Union or Member State authority, the period within which the relevant authorities are required to adopt their respective output, or the joint output referred to in paragraph 2, may be extended. After consulting the body concerned, the Authority shall lay down a period within which that information is to be provided and shall inform the Commission of the additional period needed. The Commission shall inform the business operators and the Member States concerned of the extension.

AddedRegulation (EU) 2017/745

Change 6 under “EXPLANATORY STATEMENT”

AddedINAL VOTE BY ROLL CALL BY THE COMMITTEE RESPONSIBLE