On 18 November 2016, the Directorate-General for Health of the European Commission (''DG SANTE'') has recently presented its revised draft proposals on the setting of scientific criteria for endocrine disruptors (EDs) under the Biocidal Products Regulation (EU) No 528/2012 (''BPR'') and the Plant Protection Products Regulation (EC) No 1107/2009 (''Pesticides Regulation''). Since the first time the EDs proposals were presented on 15 June 2016, they have been subject to three rounds of discussions within the Member States competent authorities (''CAs'') for biocides and the Standing Committee on plants, animals, food and feed (''PAFF''), section, Phytopharmaceutical. In addition, the drafts were consulted with the public between 30 June and 28 July 2016.
By way of a background, according to the BPR and the Pesticides Regulation, substances which are identified as EDs must not be approved, unless subject to the following derogations: (i) in the case of pesticides, there is a negligible exposure; or (ii) in the case of biocides, there is a negligible risk. The question of whether a substance is an ED would be assessed each time it is subject to an approval procedure or a renewal procedure.
The latest comments received from the Member States are reflected in three draft legal acts: i.e. (1) Revised biocides draft; the initial text concerning pesticides is now divided into two: (2.1) the first text covers the criteria – Revised pesticides criteria draft; (2.2) and the second one containing technical amendments to the clause on negligible exposure – Revised pesticides amendment draft. In parallel to the substantive legislative initiatives, and due to the complex nature of the EDs criteria, the institutional players have realised the need for an implementation tool once the draft regulations are adopted and enter into force. To that end, the European Chemicals Agency (''ECHA'') together with the European Food Safety (''EFSA'') supported by the Commission's Joint Research Centre (''JRC'') have already started working on draft guidelines which are expected to be finalised during the first half of 2017.
Critical points still remain
It is obvious from the minutes of the meetings of 18 November, that although some Member States consider that previously problematic areas are resolved with the current drafts, the majority of the them, as well as MEPs from the Parliament's Environmental Committee (''ENVI'') still have mixed feelings with regards to the approach of DG SANTE. The most controversial aspect of the new proposals is the Commission's amendment of one of the ''three commandments'' for assessing whether a pesticide substance (including pesticides containing safeners and/or synergists) or a biocidal active substance has endocrine-disrupting properties for humans. In particular, according to the June text, a substance would be defined as an ED if ''it is known to cause an adverse effect'', which now is replaced by ''shows an adverse effect''.
Firstly, some Member States and the Parliament take the view that this change substantially deviates from the World Health Organisation (''WHO'') definition, which the Commission is supposed to adhere to. Secondly, it is argued that the use of ''shows'' in conjunction with the third commandment – i.e. ''the adverse effects is a consequence of the endocrine mode of action'' – will make it almost impossible to demonstrate that a substance is an ED. Thirdly, the new terminology raises the level of evidence for EDs which would be higher compared to the one for other categories of chemicals (e.g. carcinogens, mutagens and reprotoxicants – ''CMRs'').
The revised draft regulations are being debated this week by the Environmental Council (on 19 December), as well as at the PAFF and biocides CAs meetings (on 21 December 2016). If the Member States reach a compromise, the acts will be subject to a three-month Parliamentary scrutiny. If ENVI does not agree with the final texts, the proposals would be submitted for a plenary vote, under which in order for the acts to be approved, more than 50% of the MEPs must be in favour.
NEW ECHA GUIDANCE ON DATA-SHARING UNDER REACH
On 30 November 2016, the European Chemicals Agency (''ECHA'') published the long-awaited revised Guidance on data-sharing under the REACH Regulation (EC) No 1907/2006 (''REACH'') (updated document version 3.0). The draft of the document has been subject to extensive debates between the European Commission, the Member States Competent Authorities for REACH and CLP (''CARACAL''), and ECHA since June; industry and stakeholders were consulted, as well.
In essence, the objective of this revision is to improve key aspects of REACH data-sharing in light of the clarifications and developments brought about by the Commission Implementing Regulation (EU) 2016/9 on joint submission of data and data sharing (the ''Implementing Regulation''). Detailed analysis of Regulation 2016/9 can be found in Fieldfisher's publications from December 2015 and January 2016. The new Guidance provides directions on the sharing of data within the same Substance Information Exchange Forum (''SIEF'') and between different SIEFs for phase-in substances and between multiple registrants of the same non-phase-in substances.
2. Key revisions and highlights
Sections 1 & 2:
Section 1 improves the definition of phase- and non-phase-in substances and it underlines the data-sharing obligations among registrants of both types of substances. This part also integrates the main principles of the Implementing Regulation (e.g. every effort obligation and cost sharing). It is also made clear, that albeit Regulation 2016/9 does not apply for the purposes of the Biocidal Products Regulation (EU) No 528/2012 (''BPR''), data generated under the BPR is relevant for REACH data-sharing. Section 2 provides a comprehensive description of each article of the Implementing Regulation.
Section 3 brings an update on data-sharing rules for phase-in substances by eliminating and amending out of date information and by highlighting the remaining applicability of the process of pre-registration of substances under REACH. It introduces the concept of a ''Substance Identity Profile'' and its importance for the SIEF formation. It brings forward key issues to be included in every data-sharing agreement according to the Implementing Regulation. More importantly, the Guidance shifts the burden of the data-sharing activities from the Lead Registrant to the co-registrants in general, and it introduces the need to agree on a cost sharing mechanism which includes a reimbursement mechanism. Finally, clarification about information to be provided to new potential registrant has been added.
Further to section 4, section 5 explains the cost sharing requirements clarified by the Implementing Regulation (i.e. itemisation and distinction between study and administrative costs). It provides clarification on what should be included in administrative costs. In addition, it stresses the need to consider possible future costs and variable number of co-registrants. The document explains the limited applicability of a risk premium and the need to justify it. It also clarifies an issue which has proven to be bottleneck in data-sharing negotiations – i.e. data-sharing related to read-across.
However, this new section brings confusion with regards to the so-called ''Affiliates approach'' in the context of registration and cost sharing obligations. In particular, the March 2016 version of the document was clearly insisting that in the case of an enterprise group with various affiliates which are separate legal entities, each of them has separate registration obligations, as well as separate cost and data-sharing obligations. Furthermore, it was considered that ''The approach considering all affiliate companies as one company in the calculation of shares is not in line with REACH principles of fairness and non-discrimination''. The final version of the text, which states that ''In case of companies with various affiliates which are separate legal entities each of them must fulfil its registration obligations separately. Accordingly, each separate legal entity is obliged to fulfil its data and cost sharing obligations'' leaves two issues open. First, it is unclear if indeed the shares for the costs and data shall be calculated (i) separately per legal entity (ii) or per a company group. Second, it also not clear if there will be an infringement of REACH should the industry decides to go for the second option (as the approach has been so far).
Section 6 on joint submission is revised by stressing the ''One substance-one registration'' (''OSOR'') principle and its applicability to both inquirers and SIEF members together. A new subsection on intermediates, as well as the possibility to submit a separate joint submission is added. The document also adds the option foreseen by the Implementing Regulation – i.e. making use of the right to opt-out from the jointly submitted data in cases it can be ascertained that a registrant does not need to share vertebrate data. The Guidance clarifies the need for the opting-out registrant to discuss with other co-registrants about the relevance of the information separately submitted. Finally, a new subsection about disputes concerning the access to the joint submission has been added.
Section 7 & 8:
Section 7 further elaborates on competition law compliance by adding reference to Article 102 of the Treaty on the Functioning of the European Union (''TFEU'') – i.e. the prohibition to abuse a dominant market positon. The antitrust section takes into account the numerous forms of cooperation and agreements which can exist between REACH registrants (Section 8).
EUROPEAN COMMISSION RELEASES REFIT ROADMAP ON THE PESTICIDES AND MRLS REGULATION
On 17 November 2016, the European Commission has released its roadmap on the regulatory evaluation and fitness check (''REFIT'') of the Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market (''Pesticides Regulation'') and Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin (''MRL Regulation'').
The evaluation aims to perform an evidence-based assessment of the implementation and functioning of the EU legislation on pesticides and pesticides residues. In particular, it should assess the accomplishment of the objectives, the enforcement, as well as the effectiveness of the pesticides legislation. Furthermore, the analysis has to identify the problems of compliance and underline which factors hinder the achievement of the objectives of the legislation. The REFIT exercise should identify both critical areas and best practices in order to provide solutions for future actions in this regulatory area.
The results of the evaluation will be the basis on which the Commission will draft a report to the European Parliament and the Council on the implementation of the Pesticides and the MRL Regulation. The assessment might propose improvements in the implementation practices, and equally trigger legislative proposals in this policy area.
2. Critical areas
As far as the Pesticide Regulation is concerned, apart from the areas on which the Commission is obliged by law to report to the Parliament (e.g. mutual recognition of products authorizations, the functioning of the zonal system, etc.), the evaluation would also address issues raised by industry and stakeholders in the areas of inter alia approval and renewal procedures, renewal of authorizations, approval of low-risk substances, labelling of pesticides – e.g. lack of harmonised implementation practice, high administrative burden, lack of clarity of the rules, difficulties to ensure compliance or enforcement, and adaptation to technical/scientific progress.
Pertaining to the MRL Regulation, the REFIT will cover topics such as: the scope of the regulation and certain definitions, as well as the regulatory procedures for setting, modifying, deleting and reviewing MRLs. Most importantly the assessment places special emphasis on the links between the two regulations, since pesticides substances can only be approved, if MRLs in relevant foodstuff have been set.
3. Next steps
The evidence on which the Commission will build its REFIT exercise, are the Member States' annual official control reports on enforcement and compliance set in Article 68 of the Pesticides Regulation, and Article 29 of the MRL Regulation. The REFIT process is expected to be completed in November 2018, which as noted might also provoke legislative amendments to the two regulations.
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