REACH Regulation (EC) No. 1907/2006.<br/>Part 2: Authorization and restriction of substances of very high concern.
Product Compliance.

REACH Regulation (EC) No. 1907/2006.
Part 2: Authorization and restriction of substances of very high concern.

The aim of REACH Regulation (EC) No. 1907/2006 is to improve the protection of human health and the environment by reducing the risks from the use of chemicals. Certain substances are therefore increasingly controlled by the European Chemicals Agency ECHA.
While a previous Insight dealt with a general introduction and the structure of the REACH Regulation (see: REACH Regulation Part 1), this article focuses in particular on the management of pollutants and the authorization and restriction of certain substances.

Candidate list / SVHC list.

The identification of a substance as SVHC (substances of very high concern) by the European Chemicals Agency (ECHA) is the first step for inclusion in the list of substances subject to authorization according to Annex XIV of the REACH Regulation. The candidate list contains the substances that have been identified as substances of very high concern in the EU. It is published on the ECHA website and continuously updated (2x per year), currently the candidate list contains 211 substances (as of 09.03.2021).
To be included in the list, a substance must have certain properties and be proposed either by a Member State or by ECHA on behalf of the EU Commission.

Here you can view the substances classified as SVHC:
ECHA Candidate List

List of substances subject to authorization according to Annex XIV of the REACH Regulation.

Every year, the European Chemicals Agency ECHA proposes to include certain substances on the candidate list in Annex XIV, List of Substances Subject to Authorization under the REACH Regulation. As soon as a substance has the following properties, it can be included in Annex XIV on a priority basis. In particular, this affects substances with PBT or vPvB properties: P (persistent), B (bioaccumulative) and T (toxic) or vP (very persistent) and vB (very bioaccumulative). Annex XIV covers all substances that are subject to authorization for use under the REACH Regulation. This authorization can be applied for by manufacturers, importers or the users of the substance. The deadlines specified in Annex XIV apply to the submission of an authorization application.

Restrictions on the manufacture, marketing and use of certain hazardous substances.

Annex XVII of the REACH Regulation lists substances, mixtures and articles that may not be manufactured, placed on the market or used, or may only be manufactured, placed on the market or used subject to restrictions due to unacceptable risks to human health or the environment. Annex XVII contains an overview listing the names of the substances, groups of substances or mixtures and the restriction conditions. These restrictions may be specified for a substance on its own, in a mixture or in an article. Decisions on new or changes in existing restrictions are taken by the EU Commission.

Differences in authorization and restriction according to REACH Regulation EC No. 1907/2006.

The fundamental difference lies in the respective objective of the two terms. In the case of an authorization according to REACH Annex XIV, the use of the substance is basically prohibited, the substance can only be used by means of a 'permission' (authorization). The restriction according to REACH aims to control the risks of the substances. According to this, the use of the substances is allowed, unless they are prohibited or separately regulated in Annex XVII.

The objective of the REACH regulation to improve the protection of the environment and human health is becoming more and more important nowadays. The complex set of regulations is continuously updated to maintain this high level of protection. It is the responsibility of each economic operator to exercise due diligence and to check and consistently implement updates of the regulations with regard to its products.

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Marco Mauler

Marco Mauler
Director Product Compliance

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