The REACH Regulation (1907/2006 / EC) is a continuing challenge for manufacturers, importers and users of chemicals, mixtures and products.
Although registration is not required for particular applications of a substance, nevertheless certain titles of REACH can apply for this substance. For example, obligation on data sharing and the dissemination of information to downstream users.
Substances in quantities of ≥1 mt/year only can be placed on the EU market if they are registered (with some exceptions). In the case of substances that have not yet been registered, the time and effort to be planned is significantly higher for all participants than for substances in which you can join an existing registration.
A new registration usually requires analytical services (chemophys., toxicological and ecotoxicological studies), some of which must be provided by third parties. These services can take long periods of time and cause high costs.
That’s why we recommend clarifying in a first step,
- which substances from your product portfolio are to register in which tonnage band
- which of these substances are used by your customers as intermediates under strictly controlled conditions in what quantities
The actual registration requirements and the associated effort should be clarified separately for each of your substances. Among other things, the following questions should be clarified:
- Is the substance already registered by third parties and which dossiers have been submitted?
- Does the information in the registration cover the registration requirements for your substance?
- What data is required for your registration?
- What data are available and suitable (in terms of relevance, adequacy and reliability)? (Data search)
- What information gaps need to be filled? (Possibly reduced data requirements for tonnage range <10 tpa)
- Are there studies to be commissioned?
- Can other ways of covering endpoints be considered, such as read across, (Q)SAR?
- How is the substance used by your customers?
For registrations above a tonnage of 10 tpa, a chemical safety report containing exposure scenarios for the uses must be submitted for the registration of hazardous substances.
Even if you don’t have to register any substances, possibly obligations emerge from your role as a downstream user.
Obligations of Downstream-Users
- Communication of your uses and the ones of your clients within the supply chain, respectively.
- Communication of information to safe use
- Preparation, submission of reports about non-supported uses
Safety Data Sheets
For substances and mixtures that are placed on the market safety data sheets according to the requirements of REACH- and CLP-regulation must be provided no later than with the first delivery. For registered and dangerous substances in quantities of ≥10 tpa relevant exposition scenarios for the user need to be attached. We prepare extended EU-MSDS for you.
Notification to the ECHA Classification Inventory
Classification and labelling of substances placed on the EU market needs to be notified by an adequate dossier at the ECHA, regardless of substance quantity.
Harmonised notification of hazardous mixtures to the ECHA Submission portal
According to Annex VIII of the CLP Regulation, importers and downstream users placing dangerous mixtures on the EU market must provide appointed bodies with specific information on their mixtures. The annex also specifies a harmonised format for notifications. The information contained in the notifications will be used by poison centres for emergency health response purposes in case of incidents involving these mixtures.
This obligations are due from:
- January, 1st of 2021 mixtures for professional use and for consumer use;
- January, 1st of 2024 mixtures for industrial use.
We prepare this notification in the harmonized format and submit it on your behalf. Please contact us for details and assistance.