EU Regulatory Bulletin contents - October 2014
- EU Commission publishes BPR review programme Regulation
- ECHA issues official Article 95 list of relevant substances, and respective substance and product suppliers
- ECHA publishes a Practical Guide on the Biocidal Products Regulation
- EFSA issues Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for pesticides
- EU Health Commissioner-designate devoted to final EDC criteria
- REACH Directors’ Contact Group provides recommendations on data costs
On 1 October 2014, the REACH Director's Contact Group (DCG), consisting of representatives from the European Commission, European Chemical Agency (ECHA), and industry associations, adopted two recommendation documents. The first one outlines a “Fair, transparent and non-discriminatory cost sharing in substance information exchange fora (SIEFs)”, and the second one is titled “Recommendations on sound SIEF management”.
By way of a background, in the communiqué on its previous meeting of 4 June 2014, the DCG already highlighted that it has been focusing on the costs related to the mandatory data sharing needed to fulfil the information requirements of registration dossiers. These constitute one of the main cost factors for SMEs and other companies preparing for the 2018 REACH registration deadline. The June meeting resulted in the adoption of two documents, namely ''A Checklist to hire a good consultant, first edition”, and a document on “Considerations to be made when joining an existing SIEF''. The two recommendations from October are thus supplementary. It is expected that these four documents will provide substantial orientation to companies preparing for the 2018 deadline, and especially to SMEs joining or forming SIEFs for the purpose of joint dossier submission, as well as to lead registrants having to accommodate such companies.
The first recommendation on fair, transparent and non-discriminatory cost sharing lists principles such as: SIEF members cannot be forced to pay for data and information they do not need; fairness of cost sharing should be judged on a case-by-case basis; prices for data should be differentiated, depending on tonnage bands and type of registration, etc. The document also provides guidance for co-registrants, who also need to initiate cost sharing negotiations in order to able to reach an agreement by 2018. Finally, the DCG provides information on available remedies in cases of disagreement over data cost sharing.
The second recommendation lays down key principles of transparency, fairness and communication within a SIEF.
The overall impression from the both documents issued by the DCG is that, compared to the original, rather lengthy and complicated Guidelines on Data Sharing under REACH, these recommendations are simpler and much user-friendly, making them appropriate for SMEs. This first version of the two recommendations is open for stakeholders' comments by 31 January 2015.
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