On June 1, 2007, the European Union adopted the European Regulation 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). It has multiple objectives:
- Better protect human health and the environment from the risks associated with chemical substances
- Ensure the competitiveness of the EU chemical industry
- Reduce animal testing during hazard assessments of substances
- Substitute progressively of the most dangerous chemicals (CMR, PBT, vPvB, SVHC)
REACH places the burden of proof on companies to identify and manage the risks associated with the substances they manufacture and market in the EU. Within this framework, manufacturers and importers must notify information related to chemical substances to the ECHA (European Chemicals Agency).
When a substance is of high concern, its use may be restricted or subject to authorization.
The 4 main actors :
- Manufacturer (of substances) : any natural or legal person established in the Community who manufactures a substance in the Community ;
- Importer: any natural or legal person established in the Community who imports a substance into the Community;
- Downstream user (of mixtures or articles) : any person other than the manufacturer or importer, who uses a substance on its own or in a preparation ;
- Distributor : any person who only carries out operations of storage and placing on the market of a substance, as such or contained in a preparation.
The products concerned :
- Substance : Chemical element and its compounds in the natural state, or obtained by a manufacturing process.
- Mixture : A mixture or solution composed of two or more substances without the manufacture of a new substance.
- Article : An object which is given, during the manufacturing process, a particular shape, surface or design which are more determining for its function than its chemical composition.
Radioactive substances, non-isolated intermediates and waste are not covered by REACH.
REACH registration
Importers or manufacturers who wish to place chemical substances on the market in quantities equal to or greater than one tonne per year must register the substance in the form of a dossier to be submitted to ECHA. The registration requires a certain amount of information: uses, toxicological and eco-toxicological properties, etc.
The amount of information varies according to the tonnage of the substance placed on the market :
- 1 to 10 tons/year : technical dossier containing physicochemical, toxicological and ecotoxicological data from Annex VII of REACH
- 10 to 100 tons/year : technical dossier containing physico-chemical, toxicological and ecotoxicological data from Annex VIII of REACH + a Chemical Safety Report (CSR)
- 100 to 1000 tons/year : technical dossier containing physicochemical, toxicological and ecotoxicological data from Annex IX of REACH + a Chemical Safety Report (CSR)
- More than 1000 tons/year : technical dossier containing physico-chemical, toxicological and ecotoxicological data from Annex X of REACH + a Chemical Safety Report (CSR)
Some tips for REACH registration :
- One substance = one registration, i.e. for one substance there can be only one registration. Manufacturers and importers who wish to register the same substance will have to file a joint submission.
- A fee is charged during registration
The 7 main steps to create a REACH registration dossier :
- Inquiry file
- Communication in the SIEF
- Joint submission
- Data Sharing
- Preparation of the CSR
- Preparation of the file
- Submission of the file
For more information on the registration steps, download our free infographic "7 steps to create your REACH registration dossier".
EcoMundo accompanies you in all your steps for the REACH registration of your substances. Our specialists ensure your registrations and a follow-up of your files in time (LoA management, tonnage monitoring, etc.).
Evaluation
The evaluation of registration dossiers is done by ECHA and the Member States. The purpose of this evaluation is to determine whether the substance for which the dossier has been submitted presents a risk to human health and/or the environment.
The authorization
A substance can be proposed (by a Member State or ECHA at the request of the Commission) to the register of intent for SVHC identification, i.e. a substance of very high concern. If no comments are received contesting this identification, the substance is included in the candidate list. Afterwards, recommendations are made to include the substance in the authorization list (annex XIV).
The objective of the authorization is to gradually replace SVHCs with other non-hazardous substances.
A substance is identified as SVHC when it has hazardous properties, for example:
- Meets the criteria for classification of CMR substances (carcinogenic, mutagenic or toxic to reproduction) of category 1A or 1B, according to the CLP regulation
- Persistent, Bioaccumulative and Toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to Annex XIII of REACH
- Other concerns (e.g. endocrine disruptors)
When a substance is included in the SVHC list, suppliers of the substance have some obligations to fulfill:
- Provide an SDS (Safety Data Sheet)
- Communicate information on safe use
- Respond to consumer requests within 45 days
- Notify ECHA if the article they use contains a SVHC in a quantity > 1t per producer/ importer per year and if its concentration is higher than 0.1% mass/mass.
The authorization list is included in Annex XIV of REACH and is available on the ECHA website.
It is possible to submit an authorization dossier in order to convince ECHA to grant an additional period of use for a substance included in Annex XIV.
The authorization file includes:
- A Chemical Safety Report (CSR) : cover risks related to the intrinsic properties described in Annex XIV
- An analysis of alternatives (AoA) : analysis of alternative solutions when they exist, with a study of their availability, their technical and economic feasibility as well as an examination of the risks associated with these solutions
- A substitution plan (SP) : for each use, including a timetable for substitution and/or R&D
- A socio-economic analysis (SEA) : compare the socio-economic impacts of continued use vs. discontinued use (loss of income, unemployment, impact on customers/suppliers, ...)
EcoMundo ensures the assembly of a complete custom-made Authorization file for the validation of your substances submitted to Authorization.
The restriction
Under REACH, the purpose of restrictions is to protect human and environmental health by prohibiting (or limiting) the manufacture, launch on market or use of a substance.
The restrictions are contained in Annex XVII of REACH. ECHA makes available a list of restrictions substance by substance. When there is an update of Annex XVII, the European Official Journal publishes the regulation.
The restriction may be in the form of specific conditions, for example technical measures or labelling requirements.
There are 4 phases of restriction:
- Phase I: Development and submission of a restriction proposal
- Phase II-A: Consultations
- Phase II-B: Preparation of the notice
- Phase III: Decision and follow-up
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