If companies want to continue the use of the substance after the sunset date, the application for authorisation must be submitted before the latest application date (set at least 18 months before the sunset date). The views, opinions and technical analyses presented here are those of the author, and are not necessarily those of UL LLC. Each dossier requires implementing a specific strategy, being it to define the uses, the analysis of the industrial processes and associated risks, the alternatives, or the socio-economic impacts of the banning of the substance. BPR regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment. Please upgrade your Internet Explorer to a newer version. It covers their hazardous properties, classification and labelling, and information on how to use them safely. This site is not fully supported in Internet Explorer 7 (and earlier versions). Companies may have immediate legal obligations following the inclusion of a substance in … The application for authorisation should be filed before the Latest Application Date (LAD), set at 18 months before the sunset date. 18 Substances Proposed for EU REACH Authorization List. Substances of very high concern identification; Draft recommendation for inclusion in the Authorisation List and consultation; Applications for authorisation; Submitted restrictions under consideration; Consultations on new scientific evidence; Current calls for comments and evidence; Current Testing Proposals Consequently, articles requiring the use of an Annex XIV substance can still be produced outside the EU and then imported. Please upgrade your Internet Explorer to a newer version. Authorisation List. during the recommendation of substances for inclusion in the Authorisation List. [14] ECHA strongly advise to follow these windows as plenary sessions of the two committees (RAC and SEAC) are organised in March, June, September and December of each year. In a press release published on March 5, 2020, the European Chemicals Agency (ECHA) announced that it is considering to recommend seven substances of very high concern (SVHCs) be placed on the Authorization List (Annex XIV) under REACH. While the editors of this site may verify the accuracy of its content from time to time, we assume no responsibility for errors made by the author, editorial staff or any other contributor. The CLP Regulation ensures that the hazards presented by chemicals are clearly communicated to workers and consumers in the European Union through classification and labelling of chemicals. Alternatives may exist but still need time to be fully qualified and deployed. Public consultation is one of the core mechanisms of the authorisation process. A justification that is too weak or an argumentation that is too generic may induce the granting of a shorter-than-requested review period.[20]. This process concerns manufacturers, importers and downstream users of substances. The references used may be made clearer with a different or consistent style of, From the Candidate List to the Annex XIV of REACH, The Application For Authorisation dossier (AFA), An in-depth analysis of the companies’ activity, Public consultation at the heart of the decision, Learn how and when to remove this template message, "SVHC Roadmap to 2020 Implementation Plan PDF", "Candidate List of substances of very high concern for Authorisation", "How to develop the description of uses in the context of Authorisation", "Setting the review period when rac and seac give opinions on an application for authorisation", "Guidance on information requirements and chemical safety assessment", "How to report read-across and categories", "Preparing applications for authorisation", "Meeting of the committee for risk assessment", "Taking stock of received, processed and granted applications", "Experience in the Committee for Risk Assessment", "Choix d'un consultant : points à vérifier", "Perturbateurs endocriniens : 55 ONG réclament l'interdiction en Europe de l'usage du DEHP dans le PVC", "Submission of information on alternatives by interested third parties", https://en.wikipedia.org/w/index.php?title=REACH_authorisation_procedure&oldid=972539253, Wikipedia references cleanup from July 2015, Articles covered by WikiProject Wikify from July 2015, All articles covered by WikiProject Wikify, Creative Commons Attribution-ShareAlike License.
It contains a list of substances subject to authorization under EU REACH regulation. An AfA can be made for one or several substances (in that case, grouping will need to be demonstrated on the basis of annex XI of REACH[12][13]), one or several uses applied for and by one or several companies. ECHA organises consultations to get feedback from all interested parties and to gather the widest possible range of scientific information for the regulatory processes. Substances on this list are selected from REACH SVHC list and they cannot be placed on the market or used after a given date ("sunset date"), unless an authorization is granted for their specific use, or the use is exempted from authorization. The fifth amendment of Annex XIV to REACH ("Authorisation List") was published on 14 June in the Official Journal. covering well-defined substances and UVCB substances, polymers and homologues, substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof, with ≥ 0.3% of dihexyl phthalate (EC No. An identified use focuses on the process and does not consider performances or markets questions. The POPs Regulation bans or severely restricts the production and use of persistent organic pollutants in the European Union. ECHA organises consultations to get feedback from all interested parties and to gather the widest possible range of scientific information for the regulatory processes.
This is unique source of information on the chemicals manufactured and imported in Europe. Applications are deemed received after business rules check is successfully passed and provided ECHA fees[15] are paid on time. If you are affected, act now and develop an authorisation strategy if the substance cannot be replaced by a suitable alternative. BPR regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment. The newly added substances cannot be used in the future without an authorisation being granted by the EU. Welcome to the ECHA website. To guarantee that you can make use of this transition agreement, ECHA actually recommends that you submit your application 3 months before the latest application date, in case there are issues with the business rule check that require a resubmission (ECHA Q&A ID 0572). As of this date, the use of the substance is only possible for companies which have been granted an authorisation or for those that have submitted their dossier before the Latest Application Date. The following notes are inserted for the entries 4 - 7, 10 - 12, 14 - 23, 25 and 27 - 46: The following note is inserted for the entry 40: (click the tag to search for relevant content). If this has been done, companies will be able to use the substance, even though a conclusion on the application has not been published yet. BPR regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment. The Support section provides tools and practical guidance to companies which have responsibilities under the EU chemicals legislation. Please upgrade your Internet Explorer to a newer version. The Analysis of Alternatives therefore presents all the substance's alternative solutions and contains: The Socio-Economic Analysis is a compulsory document for the socio-economic route and can also complete an application justified by the adequate control route. From this point of view, it is the supply chain of the substance that matters. The Authorisation List (Annex XIV) now contains 43 substances. The entries in Annex XIV contain two important dates: the sunset date and the latest application date. UL’s global Regulatory Assurance Team contains more than 50 regulatory analysts worldwide, serving customers in six continents, with multi-lingual support in more than 30 languages. Since REACH applies to some substances that are contained in objects (articles in REACH terminology), any company importing goods into Europe could be affected.
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