Registration Evaluation Authorisation and Restriction of Chemicals (REACh)
REACh is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.
IMPORTANT UPDATE AS OF 1ST JUNE 2018
31st of May 2018 was the last chance to submit a registration for existing (phase-in) substances manufactured or imported at above one tonne per annum. If the registration dossier obligation applied to you and you did not submit your dossier by the last day of May, as of June 1st 2018 you can no longer manufacture or import your substances legally in the EU/EEA. If you missed the deadline and want to manufacture or import your phase-in substance legally in the EU/EEA you should bring yourself to compliance.
If you have pre-registered or inquiried your phase-in substance, you can register it. (until further notice you can still use the pre-registration number)
if you have not pre-registered or inquired your phase-in substance you need to submit an inquiry before registering it.
If you submit your dossier after 31st May 2018, you will need to wait until you receive your registration number before manufacturing or importing above 1 tonne/year of your substance.
Keep scrolling down to view summary obligations, exemptions and services provided by Chemi-Compliance.
A company has a duty to comply with REACh regulations if it:
manufactures a substance or,
imports a substance
and place it on the EU market, whether by itself or as part of a formulation, in volumes greater than 1 tonne / annum.
Substances manufactured/imported and exported back out of the EU are discounted from the annual volume calculations. Simply put, if 16 tonne of Chemical A are manufactured per year, and 7 tonne are exported to non-EU states, the obligation is only for 9 Tonne.
Not all substances require registration, the exemptions are described in REACh 1907/2006 EC (as amended):
Substances listed in Annex IV: as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties. Examples are: Lactose, galactose, sucrose, Nitrogen, starch etc.
Substances listed in Annex V: as registration is deemed inappropriate or unnecessary for these substances and their exemption from these Titles does not prejudice the objectives of this Regulation
Examples are: substances manufactured on end use (such as cured resins), substances which result from chemical reaction incidental to storage, by-products (unless placed on the market), hydrates, mineral ores etc.
If in doubt, we can review the substances, chemical process and confirm whether the substances are exempt.
Initial gap analysis
SIP / Analytical work support
Inquiry dossier authoring
Registration dossier authoring
Chemical process review
Formulation / chemical reaction review
Associated C&L Notification (Article 39, CLP)
Since the implementation of the REACh regulations, there has been continuous uncertainty in the market place regarding what constitutes 'placing a chemical on the market' and what constitutes a chemical reaction. We are happy to discuss this in more detail and decide on the best course of action.
Note - we may also recommend replacing material with EU sourced alternatives where REACh registration is not deemed cost effective.
Substance Identification Profile (SIP)
As part of the registration process a suite of analytical work is required to confirm the identity of the substance. The Substance Identity Profile is provided by the relevant SIEF or Consortium.
As of the 1st June 2018, the SIP is required for:
Substance identification during the REACh Inquiry
Required to obtain an inquiry number, equivalent of a pre-registration number pre-May 2018
In order to join the SIEF / Consortium
As part of the REACh Dossier submission
Chemi-Compliance does not carry out any analytical work, but relies on third parties to carry out the work. We can arrange the analytical work with these companies on your behalf.