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:
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 :
The products concerned :
Radioactive substances, non-isolated intermediates and waste are not covered by REACH.
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 :
Some tips for REACH registration :
The 7 main steps to create a REACH registration dossier :
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.).
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.
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:
When a substance is included in the SVHC list, suppliers of the substance have some obligations to fulfill:
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:
EcoMundo ensures the assembly of a complete custom-made Authorization file for the validation of your substances submitted to Authorization.
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:
Want to know more about REACH? Contact an expert free of charge and with no obligation!
Need a newsletter to help you keep abreast of regulations and anticipate your short-, medium- and long-term obligations? Chemical Insight is the solution that helps you stay compliant while preventing the obsolescence of your chemical substances. Sign up now!
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:
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 :
The products concerned :
Radioactive substances, non-isolated intermediates and waste are not covered by REACH.
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 :
Some tips for REACH registration :
The 7 main steps to create a REACH registration dossier :
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.).
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.
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:
When a substance is included in the SVHC list, suppliers of the substance have some obligations to fulfill:
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:
EcoMundo ensures the assembly of a complete custom-made Authorization file for the validation of your substances submitted to Authorization.
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:
Want to know more about REACH? Contact an expert free of charge and with no obligation!
Need a newsletter to help you keep abreast of regulations and anticipate your short-, medium- and long-term obligations? Chemical Insight is the solution that helps you stay compliant while preventing the obsolescence of your chemical substances. Sign up now!