REACH is the abbreviation for Registration, Evaluation and Authorisation of Chemicals. The Regulation came into force 1 June 2007 and standardises the chemical legislation across Europe.

According to Article 1, aim of the REACH Regulation is to “ensure a high level of protection of human health and the environment, […] as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation”.

Manufacturers and importers have to bear most of the obligations under REACH Regulation, they are to a high extend held responsible for the safe use of chemicals.

Please find below the individual elements of the REACH Regulation briefly outlined:

Registration

Each manufacturer or importer must register substances that are manufactured or imported in quantities of 1 t or above at the European Chemicals Agency ECHA.

The data requirements are depending on the tonnage of the substance. If the tonnage exceeds 10 t per year, a chemical safety report including a safety assessment and detailed description of risk management measures will be required.

Upon registration, the substance receives a registration number, which needs to be communicated to downstream users in the safety data sheets.

Evaluation

There are two different procedures of evaluation embedded in the REACH Regulation, one is the dossier evaluation the other one is called substance evaluation.

Within the dossier evaluation the ECHA assesses weather the registration dossier is complete and if the requirements of the REACH Regulation are fulfilled. If the dossier contains testing proposals for further toxicological or ecotoxicological studies these will also be assessed at this stage.

The substance evaluation is carried out by Member Stated of the EU. Within this process all available data of the registration dossier are assessed, if considered necessary further data can be requested.

Authorisation of substances

REACH defines so-called substances of very high concern or SVHC substances. Substances that meet these criteria are published in a candidate list. For these substances certain duties with regard to hazard communication apply, especially if substances are contained in articles.

After a prioritization process SVHC substances of the candidate list can be added to Annex XIV of the REACH Regulation. When included in Annex XIV a sunset date will be set. After a transitional period, it is not allowed to further use the substances or to place them on the market for use, unless an authorisation was given by ECHA. Manufacturers, importers and downstream users may apply for authorisation of particular uses for the substances.

Restriction

Restriction according to Annex XVII of REACH Regulation means that a use of substances by itself, in mixtures or in articles is permitted.

Comparing restriction and authorisation under REACH it is evident, that within the authorisation, substances are prohibited for all uses unless authorisation is granted, while a restriction applies to a particular use and all other uses are allowed, if not regulated elsewhere.

Safety data sheets

Safety data sheets need to be compiled according to REACH Article 31 and Annex II. If a chemical safety report was prepared as part of the registration dossier, the exposure scenarios will be forwarded to the downstream users as part of an extended safety data sheet. The downstream user is obliged to compare the exposure scenarios with his use, if necessary, he may compile his own chemical safety report.

Of course, we are happy to help you meet your numerous obligations. After a detailed analysis we will put together a customized package for you.