Overview:

The REACH Directive, which stands for Registration, Evaluation, Authorization and Restriction of Chemicals, is the EU’s law for the preventive management of all chemicals entering its market. It requires that all chemicals imported and produced in Europe must pass a comprehensive set of procedures such as registration, evaluation, authorization and restriction. Any goods must have a registration dossier listing the chemical ingredients and describing how they are used by manufacturers, as well as a toxicity assessment report.

Declaration Process:

1、Registration

Requirement of registration formation is divided into four classes. The requirement is based on the amount of chemical substances, ranging from 1 to 1000 tons; the larger amount of chemical substances, the more registration information is required. When the registered tonnage is exceeded, a higher class of information and updated information will be required.

2、Evaluation

The evaluation includes both a dossier evaluation and a substance evaluation. The dossier evaluation includes a review of draft test reports and a registration conformity review.

• Review of the draft test reports is requested from registrants or downstream users with an annual production volume of 100 tons or more;
• Registration conformity review is a sample survey of the dossier of 100-ton or more submitted within the deadline, to see whether they meet the regulatory requirements or not.
• Substance evaluation is to evaluate impact of substances on human health and environment based on the materials in the dossier, checking for the presence of substances from the Candidate List SVHC (Substances of Very High Concern).

3、Authorization

For chemicals that have certain hazardous characteristics and are of very high concern (SVHC), a dossier needs to be submitted to the EU Chemicals Agency as well as the Supervisory Commission for risk assessment and application for authorization. These include:

• CMR category: carcinogens, mutagens, substances toxic to the reproductive system
• PBT category: persistent, bioaccumulative toxic substances
• vPvB category: very persistent and very bioaccumulative substances

4、Restriction

The import or production will be restricted if the risks to human health and the environment arising from the substance, configuration or their manufacture, placing on the market or use are not considered to be adequately controlled.