EU Regulatory Bulletin October | Fieldfisher
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EU Regulatory Bulletin October



Welcome to this month's EU Regulatory Bulletin.

EU Commission publishes BPR review programme Regulation

Following up on a draft from earlier this year, on 10 October 2014, the Regulation No 1062/2014 on the review programme for existing active substances under the 528/2012 Biocidal Products Regulation (BPR) was published in the EU Official Journal. The Regulation, in the form of a Commission delegated act, lists all substances and their product-types (PTs) that are currently supported for review and included in the review programme, as well as those that are not supported.


ECHA issues official Article 95 list of relevant substances, and respective substance and product suppliers

The first official Article 95 list of relevant substances, and respective substance and product suppliers in the EU was published by the European Chemical Agency (ECHA) on 24 September 2014. This list represents one of the core changes under the Biocidal Products Regulation 528/2012 (BPR), whereby ECHA is trying to establish a level playing field between data owners and non-data owners such that every market actor contributes to the review of the relevant active substances concerned. Biocidal products cannot be made available on the EU market from 1 September 2015 unless either the active substance or product supplier is on the list for the appropriate active substance/product type (PT) combination. 


ECHA publishes a Practical Guide on the Biocidal Products Regulation

On 23 September 2014, the European Chemical Agency (ECHA) issued a Practical Guide on the Biocidal Products Regulation (BPR). The document consists of the following chapters: approval of active substance; Article 95: list of active substances and suppliers; technical equivalence; national authorisation; mutual recognition; renewal of national authorisation and authorisations subject to mutual recognition; Union authorisation; simplified authorisation; changes of biocidal products; data sharing; appeals (on ECHA decisions). Additional sections on renewal and review of approval of active substance, as well as research and development are expected to be published at the end of October 2014.


EFSA issues Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for pesticides

On 23 October 2014, the European Food Safety Authority (EFSA) published new Guidance document which for the first time harmonizes the method for calculating the exposure to plant protection products (PPPs) for four major social groups – operators, workers, residents and bystanders.


EU Health Commissioner-designate devoted to final EDC criteria

During his confirmation hearing before the European Parliament on 30 September 2014, the EU Health and Food Safety Commissioner-designate Vytenis Andriukatis announced that he will aim to overcome obstacles on finding conclusive criteria for endocrine disrupting substances (EDCs) under the biocides and pesticides legislation.


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”.


Ongoing public consultations

Commission consultation on DEHP in medical devices

On 23 October 2013, the European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) adopted a preliminary Opinion on the safety of medical devices, which contain DEHP-plasticised PVC or other plasticisers. As a result, the Commission has initiated a public consultation on that Opinion.

The document is open for comments until 30 November 2014.

New CLH consultation launched on the pesticide triadimenol

ECHA has started a 45-day public consulation on the harmonised classification and labelling (CLH) proposal for triadimenol (EC No. 259-537-6, CAS No. 55219-65-3).

The substance triadimenol is used as a fungicidal seed and foliar spray treatment in agricultural applications on the EU market. Since the substance does not yet have harmonised classification, the dossier submitter - the United Kingdom - is proposing classification for health and environmental hazards.

The deadline for submitting comments is 28 November 2014. More information on the consultation can be found on ECHA's website.