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07/02/2018

EU Chemicals regulatory news, 7 February 2018

ECHA to prepare restriction proposals for oxo-plastics and intentionally added microplastic particles

The European Commission has instructed ECHA to prepare restriction proposals for oxo-plastics and intentionally added microplastic particles. The measures reflect the European Commission's strategy on plastic waste, unveiled as part of the Circular Economy Package of 16 January 2018. Oxo-plastics, which facilitate the degradation of polymer materials into very small particles, contribute to microplastic pollution. 

At the same time, some microplastic particles are intentionally added to certain consumer and professional products, including cosmetics, detergents and paints, and pose a potential risk to the environment and human health. The stakeholder consultation on ECHA's proposals is expected to take place in spring 2018.  

Registrants to contract testing houses before end of March 2018 in order to seek benefit of an "exceptional case"

By a communiqué published in December 2017, the Directors' Contact Group (DCG) reactivated some of its previous practice (called "Solutions"), ahead of the May 2018 registration deadline. One of such revived issues relates to testing data not being available by the May 2018 registration deadline. In line with its previous practice, ECHA has indicated its preparedness to grant registrants a reasonable time period to complete dossiers after a registration deadline.   

In a separate communication, Notice on contacting ECHA to provide information about being in an exceptional situation as identified by the DCG, the DCG has instructed prospective registrants, and in particular Lead Registrants, that missing tests must be ordered by the end of March 2018 in order to seek the benefit of an exceptional case. The Notice lists also other criteria (under Issue 10.3 - Data required in Annexes VII and VIII of REACH not yet available by the registration deadline) that must be fulfilled for an exceptional case to apply. At the same time, the Notice stressed that ECHA retains full discretion whether to grant the benefits of an exceptional case. 

Germany has challenged the remits of the competence of ECHA Board of Appeal 

Germany has launched an action against ECHA before the EU Court of Justice. The background to Germany's legal action lies in the decision of ECHA's Board of Appeal in Case A-026-2015, which concerns a request for further information for the substance 1,4-Benzenediamine, N,N'-mixed phenyl and tolyl derivatives (so-called "BENPAT") used in the production of car tyres, following a substance evaluation conducted by the German national competent authority. In its decision, ECHA Board of Appeal partially annulled ECHA's decision by which the registrant was requested to undertake further testing to ascertain the persistent, bioaccumulative and toxic properties of the substance.    

Germany maintains that ECHA Board of Appeal exceeded its powers by having conducted a comprehensive examination and re-assessment of ECHA's substance evaluation decision. According to Germany, ECHA Board of Appeal lacks competence on substance issues relating to evaluation procedures and, in line with established case-law, independent decision-making power as a body of an EU agency. 

The judgment of the EU Court of Justice is expected to be significant in clarifying the confines of competence of ECHA's Board of Appeal.

Biocides: Sweden's national competent authority, KEMI, raises lack of clarity and inconsistencies in interpretation of treated articles

In a letter addressed to the European Commission's Directorate-General for Health and Food Safety, the Swedish national competent authority, KEMI, has raised inconsistencies in the interpretation of treated articles and biocidal products in the context of textiles. According to KEMI, these inconsistencies could undermine the forthcoming, first enforcement project by the Biocidal Products Regulation Subgroup of the Forum for Exchange of Information on Enforcement, foreseen for 2019. As the enforcement project relates to treated articles, it is paramount to have clarity and consistent view across the Member States as to which impregnated clothing items shall be considered treated articles, as opposed to biocidal products.

Cosmetics: Finnish national competent authority, Tukes, focused inspections on cosmetic products 

The Finnish national competent authority, Tukes, inspected around 400 cosmetic products in 2017, which represented a significant increase in inspections to previous years. The most common type of non-compliance issue related to incorrect and insufficient labelling (most notably, the lack of labelling in the official languages). At the same time, prohibited ingredients were discovered in nine products. Around 70 products contained preservatives or preservative mixtures, the use of which was prohibited in the specific product. The most serious individual finding related to a sunscreen, which lacked UV-filters. A total of 4 (administrative) decisions were taken by which the sale of some 27 cosmetic products was prohibited. In other cases, non-compliant cosmetic products were voluntarily withdrawn from the market or measures were taken to rectify deficiencies. 

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