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EU Regulatory Bulletin September

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Belgium

Welcome to this month's EU Regulatory Bulletin.

Fieldfisher wins three EU contracts for the drafting of BPR guidance

At the end of August this year, the European Commission awarded Fieldfisher three contacts for the drafting of EU guidelines under the Biocidal Products Regulation (BPR). The guidance documents are intended to assist SMEs with practical advice on data sharing, consortiums and letters of access.

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ECHA is consulting internally on guidance on Article 95 list of the BPR

On 3 September 2014, the European Chemical Agency (ECHA) circulated internally a draft version 2.0 of the guidance document on active substances and suppliers - Article 95 list of the Biocidal Products Regulation (BPR). The intention of Article 95, as described in recitals 8 and 58 of the BPR, is to ''ensure the equal treatment of persons placing active substance on the market'' and to establish a ''level playing field [...] on the market for existing active substances''.   

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Fieldfisher expresses a strong opinion on Article 58 (2) of REACH

On 15 September 2014, Chemical Watch published an interview with Partner Claudio Mereu, who was a speaker during the Informa Chemical conference in Barcelona on 9 September. The interview entitled ''ECHA's assessment of regulated substances superficial'' was reported by the media as follows.

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ECHA publishes guidance on chemical safety assessment

The European Chemical Agency (ECHA) has recently issued practical guidance to assist with the information requirements with regards to chemical safety assessment under the REACH Regulation. The document is important also for providing instructions on how to prepare a chemical safety report (CSR). On its part, the CSR may be an imporant element of a registration dossier, downstream user obligations, or an authorization application. In addition, the guidance document explains the basic principles to be taken into account in the preparation of a risk assessment. Finally, ECHA used the opportunity to update a chapter on mutagenicity testing, which itself forms part of a series of documents to help various stakeholders in fulfilling their obligations under REACH.

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ECHA publishes REACH and BPR data-sharing dispute decisions

ECHA made publicly available all 27 data sharing dispute decisions which have been issued under the REACH Regulation and the Biocides Products Regulation (BPR) to date.

The legal basis for bringing a data-sharing claim is set in Article 30 (3) of REACH. The most frequent issues invoked in the twenty-five RAECH disputes include, amongst others: lack of transparency regarding cost breakdown and cost sharing mechanism; the existence of a price not dependent on tonnage band; unjustified annual increase of letter of access price.

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Ongoing public consultations

ECHA launches a consultation on 22 substances for REACH authorization

As a part of its sixth recommendation of chemicals to be included in Annex XIV of the REACH Regulation (the authorisation list), the European Chemical Agency (ECHA) started a consultation on 22 substances. It is the first time the Agency consults on such a large number of chemicals, compared to the average of eight per year which it normally proposes.

Simultaneously, the institution in Helsinki is also assisting in a parallel consultation initiated by the European Commission on the possible social, economic, environmental and health impacts if the said substances are included in the Annex. 

The draft list will be the first one to be compiled by ECHA's Member State Committee (MSC) on the basis of an updated approach on prioritising candidate list of substances for inclusion in the authorisation list. Particularly, the list consists of several groups of chemicals:

  • Seven lead chemicals;
  • Two coal tar chemicals;
  • Four boron substances;
  • Seven phthalates;
  • As well as: 4-nonylphenol, branched and linear, ethoxylated; and 1-bromopropane.

The consultation is open until 30 November; more information can be found on ECHA's website. ECHA consults on SVHC proposals

ECHA commenced a consultation on ten proposals for substances of very high concern (SVHC). The Member States which have submitted the proposal dossiers are Austria, Denmark, Germany, and Sweden. 

The deadline for comments is 16 October, and the list of the substance can be found on ECHA's website.

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