EU Chemicals regulatory news, 9 March 2018
REACH Review: Regulation has enhanced protection of human health and the environment but room for improvement remains
The European Commission has concluded that, after 10 years in operation, the REACH Regulation has delivered in enhancing the protection of human health and the environment, as well as promoting alternatives to testing methods. However, at the same time, there remains room to improve the efficiency of chemicals management in the EU. This applies in particular to evaluation, and the risk management process of authorisation and restriction.
One of the main issues of concern remains the quality of registration dossiers and their high rate of non-compliance. Indeed, ECHA's Progress Report 2017 outlines that by the end of 2017, ECHA has made closer to 2,600 information requests and the overall non-compliance rate was around 73%. The non-compliance rate was 69% for dossiers submitted in the highest, over 1,000 tn/a, band and 77% in the second highest tonnage band (100-1,000 tn/a). ECHA observes that it has already taken measures to improve the level of dossier compliance, and it is in the process of further developing remedies and to enhance the efficiency of the evaluation processes.
EU Member States endorse authorisation applications for certain chromates used in motor and aeronautics applications
The EU Member States, acting through the REACH Committee under the auspices of the European Commission, have endorsed at their latest meeting in the end of February 2018 a number of applications for authorisation. These include, for instance, the use of certain chromates (most notably chromium trioxide, sodium dichromate and potassium dichromate), including in mixtures, used in civil and military aerospace applications as well as in coatings for connectors. These applications, for which the review periods end in 2021 and 2029, respectively, remain subject to a formal decision by the European Commission.
At the same time, the European Commission has published the final decision authorising the use of sodium dichromate as a corrosion inhibitor. The decision was taken pursuant to an application by Total Raffinerie Mitteldeutschland GmbH. The recommended review period expires in September 2029. The decision is based on socio-economic considerations, which outweigh the human health risks, there being no suitable alternative substances or technologies available to the applicant company before the sunset date (i.e., the date after which the substance cannot be placed on the market or used unless an authorisation has been granted or an application for authorisation has been submitted).
Food contact materials: Two new EU authorisations for plastic Food Contact Materials notified to the WTO
The European Commission notified the World Trade Organisation of amendments to Regulation (EC) No. 10/2011 on plastic materials and articles intended to come into contact with food at the end of February 2018. The amendments reflect the authorisation of the use of two new substances (1,2,3,4-tetrahydronaphthalene-2,6-dicarboxylic acid, dimethyl ester; and [3- (2,3-epoxypropoxy)propyl]trimethoxy silane). At the same time, the applicable specific migration levels for two other substances (perchlorate; and phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1- dimethylpropyl)phenyl triesters) have been changed (lowered for the former and increased for the latter).
The amendments to the regulation follow scientific opinions adopted by the European Food Safety Authority (EFSA) earlier. Plastic materials and articles complying with Regulation (EC) No. 10/2011 before the entry into force of the amendments, foreseen in June 2018, may be placed on the market during the following 12 months and they can be sold until exhaustion of stocks.
Cosmetics: Public consultation on phenylene bis-diphenyltriazine (S86) as UV-filter in sun blocker
The Scientific Committee on Consumer Safety (SSCS), which operates under Directorate-General Health and Food Safety (SANTE) of the European Commission, has opened a consultation on phenylene bis-diphenyltriazine (S86). The consultation closes at the end of April 2018. Based on the SSCS' preliminary opinion, the substance is safe for use as a UV-filter in sunscreen products at a concentration up to 5%.
However, as no data has been provided on safety via inhalation, the SCCS has considered use to be safe only in dermally applied products but not in products that could lead to inhalation exposure. Furthermore, as the substance may contain impurities that are classified as carcinogenic, mutagenic or reproductive toxic ("CMR"), and identified as Substances of Very High Concern ("SVHC") pursuant to the REACH Regulation, the levels of the impurities should be kept at trace levels. The potential effects of the substance on the environment have not been assessed.