EU Regulatory Bulletin - March 2015
Practical Guides – Special series released on data sharing, letters of access, and consortia
In August 2014, the European Commission awarded Fieldfisher three contacts for the drafting of EU guides under the Biocidal Products Regulation (BPR). The guides are intended to assist SMEs with practical advice on data sharing, consortiums and letters of access.
Fieldfisher, led by partners Koen Van Maldegem and Claudio Mereu, submitted joint bids with CEFIC (the European Chemical Industry Council), UEAPME (the European Association of Craft, Small and Medium-sized Enterprises) and AISE (the International Association for Soaps, Detergents and Maintenance Products) for all three tenders. During the work process, Fieldfisher and partners collaborated with the Commission, the European Chemicals Agency (ECHA), Member States and various stakeholders.
The three Guides are now available as official documents on ECHA's website.
ECHA updates Article 95 list
On 27 February 2015, ECHA updated the list of relevant substances and the respective substance and product suppliers, in accordance with Article 95 of the Biocidal Products Regulation (BPR), as amended by Regulation (EU) No 334/2014 of 11 March 2014.
Considering the approaching 1 September 2015 deadline, it is crucial for substance and product suppliers, who wish their biocidal product to be available on the EU market after that date, to adhere to Article 95(2) of the BPR.
The last version of the list can be found here.
EDs criteria still controversial for EU chemicals regulation
In February 2015 DG SANTE published its responses to the public consultation launched in December 2014 as part of the roadmap for identifying criteria on endocrine disruptors (EDs) in the context of the implementation of the Plant Protection Products Regulation 1107/2009 (PPPR) and Biocidal Products Regulation.
Opinion of Advocate General Kokott on the future of SVHCs notification obligations
On 12 February 2015, Advocate General Kokott delivered an important Opinion in case C-106/14, FCD and FMB. The case is a request for a preliminary ruling from the French Conseil d’État (Supreme Court) and it concerns the concept of ''article'' under the REACH Regulation, and the duty to notify concentrations of Substances of Very High Concern (SVHCs).
Ongoing public consultations
EU Health Commissioner-designate devoted to final EDC criteria
The first substance, 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5) is used as a plasticiser and lubricant. The second substance, 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane , 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane  [covering any of the individual isomers of  and  or any combination thereof] is a group entry and substances falling under this entry include for example, Karanal.
The deadline for submitting comments is 16 April 2015 on ECHA's website.
REACH Authorisation - Consultation on applications for low volumes and on extension of transitional arrangements for uses in legacy spare parts
On 5 February 2015, the European Commission's Directorate-General for Growth opened a public consultation on streamlining and simplifying the REACH authorisation application procedure for applications concerning uses of substances in low volumes and on a one-time extension of transitional arrangements for uses of substances in legacy spare parts.
The consultation is open for comments until 30 April 2015, and can be found on the following link.