The European Chemicals Agency has published two important documents in connection with the evaluation process in accordance with Regulation REACH: First Action Plan Community assessment of substances and a summary report of the evaluation of registration dossiers in 2011
The first blueprint for Community Action, which initiates the process of evaluation of substances under REACH, submit a list of priority substances for evaluation in order to clarify whether production or use pose a risk to human health or the environment. Substances for evaluation under this plan are selected based on scientific criteria and criteria based on risk. In this regard, the Agency has published updated supporting documents concerning the assessment of the substance to help a better understanding of this new process as a way to collect new information on chemical substances. Member States will assess certain substances in order to determine whether their use poses a risk to human health or the environment. In the course of this assessment process is possible, if necessary, request additional information from the registrants of a ingredient that is assessed to verify suspected alarms. The assessment may indicate that risks are adequately controlled with existing measures or lead to a proposal for measures for risk management at European Union level. Risk management of chemicals requires commitment from both the industry and by the competent authorities. Further information on the evaluation process of substances and detailed action plan for the Community was published on the Agency’s website.
As part of the evaluation process under CE certification – REACH European Chemicals Agency publishes an annual report on the evaluation of registration dossiers in 2011. The report summarizes the main issues that registrants should pay attention to compliance with the registration requirements and identifies the most frequently identified discrepancies in registration dossiers, making specific recommendations to registrants in this area and in particular on the applicability of specific tests on the substance and the identity of the substance. The Agency draws attention of registrants in 2013 and recommends using the guidelines of the report to avoid mismatches, safety assessment, hazard assessment, assessment of persistence, bioaccumulation and toxicity (PBT), exposure assessment and its scope, risk characterization and classification and labeling.
ECHA and CE certification added twenty new substances to the list of candidates for authorization under REACH after consulting the Committee of Member States. In December 2011 candidate list of substances of very high concern contained 73 substances and is published on the Agency’s website. According to REACH Regulation, companies that produce, import or use substances on the candidate list on their own, in mixtures or in articles have obligations arising from the date of the inclusion of these substances in the list. Manufacturers and importers 0.1 weight. %. The obligation to notify substances in articles is not applicable if the substance is registered for a particular use or the manufacturer / importer can prove lack of exposure. They are obliged to inform (notify) the Agency for the presence of substances in the candidate list within six months from the date of their inclusion in the event that fulfills the following two conditions: the substance is present in the produced / imported articles in quantities totaling over 1 t / d for all products containing it to the manufacturer / importer, and its concentration in these products is over 0.1 wt. %. The obligation to notify substances in articles is not applicable if the substance is registered for a particular use or the manufacturer / importer can prove lack of exposure.
ECHA publishes list of classification and labeling of substances in accordance with Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP). The list contains information on classification and labeling of notified and registered manufacturers and importers of substances, including applicable harmonized classifications in accordance with Table. 3.1, and is published on the website of the European Chemicals Agency. Database classification and labeling is compiled and maintained by the Agency based on information from registration dossiers and notifications of companies, the data will be updated periodically as new information from the growing number of notifications and registrations of substances.
Name in the IUPAC nomenclature for substances classified in certain classes or categories of danger, according to Art. 119 (1) (a), without prejudice to art. 119 (2) (e) and (f) of the REACH Regulation on CE certification. For more information on these and related topics you can visit http://www.ceway.eu/, which offers you EU cosmetics regulatory and testing solutions and consultancy.