Anyone involved in the preparation of safety data sheets cannot avoid the REACH Regulation . Although the REACH Regulation is mainly relevant for manufacturers or importers of pure substances, it also contains important content for manufacturers of mixtures. The REACH Regulation consists mainly of annexes. In today’s blog post, I would like to tell you more about the contents of these annexes.
Content of the REACH Regulation
The REACH Regulation consists of various titles. These include, for example, information on the obligation to register, rules on avoiding animal testing or obligations for downstream users. The aim behind this is to protect health and the environment, but also to improve innovation and competitiveness. In addition to these titles, which are divided into articles, the REACH Regulation consists of 17 annexes. I would now like to discuss the most important annexes for mixture manufacturers and SDS creators.
Annex II – Structure and contents of the safety data sheet
Annex II of the REACH Regulation is probably the annex most familiar to SDS creators. It regulates how a REACH-compliant safety data sheet is structured and which contents must be listed in the individual sections. So if you want to read up on the name of section 8, which physical and chemical properties have to be listed in section 9 or what section 10 contains at all, Annex II is the right address.
Annex XIV – Substances subject to authorisation
We have already covered the content of Annex XIV of the REACH Regulation in a previous blog post. This Annex is also probably one of the better known – it contains the substances subject to authorisation, also known as the REACH Candidate List.
Annex XVII – Restrictions on substances
We have already devoted a separate article to the contents of Section XVII. Here it is regulated for which substances or groups of substances restrictions on manufacture, placing on the market and use must be observed. At the beginning of the year, the effects of this annex were also publicly discussed, as certain substances may now no longer be used for tattooing purposes.
Annex I – Chemical Safety Assessment
For manufacturers and importers of pure substances, this annex is of greatest importance, as it regulates how the chemical safety assessment is to be carried out and how chemical safety reports are to be prepared.
And what about the rest?
The REACH Regulation contains 17 annexes, four of which I have now dealt with. This raises the question of what the remaining 13 annexes say. These annexes also contain information that largely concerns the registration of pure substances. For example, Annexes VII, VIII, IX and X give standard data requirements for manufactured or imported substances depending on the quantity. Someone who imports one tonne per year has different requirements than a manufacturer of 1000 tonnes of a pure substance. It would be very extensive to go into each of the 13 annexes individually here.
However, one or the other annex will certainly be the subject of one of our blog posts in the future. Legal texts in general are often complex and not easy to understand. For this reason, the REACH Regulation requires safety data sheets to be prepared by a competent person. Feel free to read this blog post (German version) to find out what is meant by this.
 Regulation (EC) No 1907/2006 (REACH Regulation), consolidated version of the REACH-CLP Biocide Helpdesk, as of 01.10.2021