Article 5 April 2018

EU Chemicals regulatory news, 5 April 2018

Cosmetics: The European Commission committed maladministration by failing to grant access to cosmetics nano inventory

The European Ombudsman has found the European Commission's refusal to grant access to the cosmetics nano inventory to have constituted an instance of maladministration. The European Ombudsman's decision follows a complaint lodged by the environmental group ClientEarth, which sought access pursuant to Regulation (EC) No 1049/2001 to a catalogue of nanomaterials used in cosmetic products and the related notifications made by cosmetics manufacturers pursuant to the EU's Cosmetics Regulation (EC) No. 1223/2009 to the cosmetic products notification portal.

The European Commission had refused access on grounds that the requested document did not exist at the time of the request, the regulator having failed to complete the compilation of the catalogue on time, and arguing that it had no existing search tool to extract the requested notifications from the database. The European Ombudsman considered that while the final version of the catalogue had not been published at the time of the request for access, the European Commission should have clarified with the group whether it wished to access any of the existing draft versions. The European Ombudsman also found, contrary to the European Commission's claims, that notifications could have been extracted from the database.

In a separate development, the European Commission has opened consultations on two nanomaterials in cosmetic products. The regulator's Scientific Committee on Consumer Safety (SCCS) has launched consultations on styrene/acrylates copolymer (nano) in leave-on cosmetic products and colloidal silver (nano) in cosmetics, including toothpaste and skin care products. The consultation periods end on 11 and 15 May, respectively.

REACH: Board of Appeal finds inadmissible a challenge against ECHA decision granting a registrant of charcoal, which has sought a complete opt-out from a joint submission, access that joint submission

The ECHA Board of Appeal has found inadmissible an appeal raised by a lead registrant against ECHA's decision by which the regulator granted access to a registrant to the joint submission for charcoal where, in the circumstances, that registrant wished to completely "opt-out" from information submitted by the lead registrant in the registration dossier. The background, and the present parties' conduct, reflects an earlier ECHA Board of Appeal decision (Case A-022-2013) according to which a REACH registration is to be considered incomplete if it is entirely separate from a joint registration for the same substance.

In reflection of that earlier decision, ECHA changed its procedures and has required, as of June 2016, a prospective registrant of a previously registered substance to provide a passcode (commonly referred to as a "token") when submitting its own registration dossier. This applies equally where the prospective registrant wishes to completely opt-out of the joint registration and not to share data. To obtain a token, a prospective registrant would normally negotiate on the terms of access with the lead registrant, and failing an agreement thereon, the matter can be brought to ECHA for a resolution under the REACH data-sharing provisions.

In the present case, the registrant had requested a token but no access to data from the lead registrant. As the parties failed to agree on the financial terms for the token, the matter was brought before ECHA. The latter sided with the registrant and granted a token to the charcoal joint submission.

While ECHA Board of Appeal ultimately found that it lacked competence to adjudicate on the issue, the contested ECHA decision having been adopted pursuant to Article 11 of the REACH Regulation which for the board lacks competence, it still made -- interestingly -- a number of observations on the requirements of the "one substance, one registration" principle in the context of a complete opt-out and the import of Article 11 of the REACH Regulation. In particular, a registrant relying on a complete opt-out and having made this known to ECHA and the lead registrant, cannot be prevented from making a separate submission for a previously registered substance. In this context, ECHA is not required to examine first whether the prospective registrant has satisfied the requirement of "every effort" to agree on the terms of access to a token from a lead registrant.

REACH: ECHA publishes Guidelines on the application of REACH restriction on PAHs

ECHA has finalised its guidance on the application of the restriction of polycyclic aromatic hydrocarbons (PAHs) to articles, as contained in Entry 50(5)-(6) of Annex XVII to the REACH Regulation. This entry prohibits the placing on the market for supply to the general public of any article, the rubber of plastic components of which come into direct as well as prolonged contact, or short-term repetitive contact, with human skin or the oral cavity under normal or reasonably foreseeable conditions of use and contain more than 0,0001% by weight of any of 8 PAH substances identified in that entry. Entry 50(5) provides a non-exhaustive list of the types of articles to which the restriction applies.

ECHA's guidance seeks to provide assistance to producers, importers and distributors of articles in complying with the restriction by explaining the scope of several key concepts, such as "placing on the market to the general public" and "normal and reasonably foreseeable conditions of use", and providing examples of the types of sports and household articles that fall within, or outside as the case may be, of the restriction.

Brexit: No role for the United Kingdom in EU institutions, including bodies of the EU agencies, post- Brexit

The European Council published guidelines in the end of March 2018, which provide a high level outline of the relationship between the EU and the United Kingdom following Brexit. Amongst one of the issues clarified in the guidelines is the involvement of the United Kingdom in EU's decision-making bodies after its departure from the Union. The guidelines state in unequivocal terms that "(…) the Union will preserve its autonomy as regards its decision-making, which excludes participation of the United Kingdom as a third-country in the Union Institutions and participation in the decision-making of the Union bodies, offices and agencies." The United Kingdom will thus have no role or participation in the EU's decision-making bodies, including also the European Chemicals Agency and its various committees.

This statement runs counter to the aspirations espoused by the British Prime Minister, Ms. May, in early March 2018 when she voiced the wish to explore the possibility for the United Kingdom to remain part of certain EU agencies, which are critical, inter alia, for the chemicals industry (i.e., ECHA).

In the meantime, work has been initiated in the United Kingdom to set up a post-Brexit framework for chemicals regulation. To this effect, investments have been made to national IT capabilities for the registration of chemical substances, thus ensuring business continuity after the United Kingdom's departure from the EU.

Assessment of public health risks from oil and gas exploration "very poor" in the EU according to the European Commission

The European Commission's Scientific Committee on Health, Environmental and Emerging Risks ("SCHEER) has found the quality of scientific assessment of possible public health risks from onshore oil and gas exploration and extraction in the EU to be "very poor". In its preliminary Opinion, published in March 2018, SCHEER highlighted that over 1,300 chemicals may be released into the environment from onshore oil and gas activities. These include chemicals that have reproductive and developmental toxicological as well as carcinogenic properties. While the likelihood of environmental release of these chemicals is relatively low under normal operative conditions, the risk of accidental spillages is high, and their physico-chemical properties and environmental behaviour differ greatly.

The Committee noted that most studies in this area originate from the United States, and rely on relatively "crude exposure estimates, which is likely to lead to attenuation of dose response functions". The studies do indicate, however, that there may be an increased risk of certain cancer types and of adverse birth outcomes in populations that live close to onshore oil and gas exploration and exploitation sites. Evidence of such a link ranges from weak to moderate wherefore the possible link cannot be ignored. Data gaps remain, however, and these should be investigated. To this effect, SCHEER has proposed, inter alia, a centralised and harmonised inventory of all oil and gas exploration sites in EU-26, analytical and modelling studies to identify and quantify exposure mixtures and their levels close to such sites, and the conduct of large-scale epidemiological studies with accurate exposure assessment.

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