Chemical managment and REACH regulation
Although sustainability is increasingly important for the industry and society, chemicals management is seldom directly linked to the sustainability strategies of the companies. Therefore, chemical management is more directed by business strategies, regulatory requirements and customer demands.
The REACH regulation states that chemical manufacturers and importers are responsible for the risk management of the substances they bring into the EU market. In additon, companies are asked to report on how products can be used in a safer manner. Should companies fail to comply, fines may be imposed by the authorities. The use and manufacturing can also be restricted, which can cause operational disruptions and a tedious process of finding an appropriate substitute.
REACH registration services
To help you meet your REACH registration obligations Wintzell & Fried provides a range of dossier preparation services:
- Advise you on the information required for your registration and any compliance issues
- Connect with other potential registrants for agreement on substance identity and acquire data and/or Letter of Access (LoA).
- Complete robust study summaries and study summaries and compile Exposure Scenarios and Chemical Safety Reports (CSRs)
- Prepare registration data and create a dossier in IUCLID 6.
- Oversee submission of the dossier to ECHA via REACH-IT.
What needs to be registered?
Registration is required for all substances manufactured or imported in quantities of ≥1 tonne/year per manufacturer or importer, unless they are exempted. The following substances are exempt from REACH registration:
- Substances exempted from REACH regulation are radioactive substances, substances under customs supervision, substances used for national defense, non-isolated intermediates, wastes, etc.
- Substances regulated by other legislation are substances in food, medicinal products, plant protection products, etc.
- Substances in REACH annex VI, which is a list of exempt substances that are well known to be safe, i.e. water, oxygen, nitrogen.
- Substances covered by REACH annex V, which are byproducts, naturally occurring substances, impurities, etc.
The following requirements are needed for the submission:
- Registration fee for each substance and individual registrant. The fees depend on the size of the company/registrant, the tonnage band and if the submission is a single or joint submission.
- A Technical IUCLID Dossier.
- A Chemical Safety Report, for substances in quantities >10 tonnes/year.