Regulatory compliance for chemical, cosmetic and biocidal products.
CHEMICALS
New chemical notification
Services
Alchemy Compliance can help with all the steps involved in new chemical notification. For the pre-notification work, we can search EINECS and ELINCS, advise on notification strategies (especially important if you require world-wide notification), and undertake any preliminary negotiations with the appropriate authority. We then advise on testing, including the use of literature data and structure–activity relationships (eg read-across or grouping), and place studies with the laboratories most appropriate to your needs. We use your commercial data, and compile the SDS and preliminary risk assessment to complete the dossier for submission to the Authorities. After the dossier is submitted, we take care of the negotiations with the authority to ensure a successful outcome. We are also able to offer our services as sole-representative notifier to non-EU manufacturers to protect your confidential information.
Further information
New chemicals – How To Get Them To Market
Before marketing a new chemical, the manufacturer or importer has to demonstrate that the product can be used safely. The applicant or 'notifier' does this by submitting a dossier on the new chemical, comprising its identity, patterns of manufacture and use, hazard information, proposed classification and labelling, and if hazardous, a safety data sheet and risk assessment, to the appropriate authority.
If you are considering marketing a new chemical, the first step is to ensure that it is indeed new by checking the EINECS inventory. This lists ca. 100 000 existing substances, defined as those on the market before September 1981, which do not require notification. Concern that little hazard information is available on existing substances has led to the REACH legislation. Most substances not on EINECS are defined as new, and require notification, although polymers have different rules.
The next step is to make an enquiry, with structural and spectral data, to your local competent authority to determine whether the chemical is listed in the ELINCS inventory. You can check this inventory yourself, but the authority is required to check it before giving approval for animal testing. ELINCS lists the substances that have been already notified. If your new chemical is on this inventory, then you are obliged to contact the first notifier to try and share the hazard data and prevent duplicate testing. The applicant still has to make the notification, but can sometimes refer to data submitted by the first company.
If the new chemical is not listed in these inventories, then the applicant has to provide new data to complete the dossier. The amount of hazard testing data depends on the amount of new chemical to be marketed. The tonnage bands are 10–100 (Annex VIIC), 100–1000 (Annex VIIB), and >1000 kg per annum (Annex VIIA or base-set). The requirements are given in the Annexes of Council Directive 92/32/EEC (the Seventh Amendment of the original Dangerous Substances Directive, 67/548/EEC). There are extra tonnage bands above 1000 kg per annum (so-called leve1s 1A, 1B, and 2 at 10, 100, and 100t, respectively), but the data requirements for these are dependent on the risk assessment at the base-set level. Usually, the data requirements are fulfilled by laboratory testing using very specific methodology (Annex V methods and Good Laboratory Practice), although some tests can be replaced with an expert statement, read-across data, etc.
Non-European manufacturers cannot make the notification directly to a European authority. Often, they designate an importer to be their notifier. Multiple importers in separate EU countries can lead to multiple notifications. Alternatively, the manufacturer can appoint a single 'sole-representative notifier' to compile tonnage data on behalf of all the European importers. This is particularly useful when the non-EU manufacturer wish maintain confidentiality of commercial information from importers.
Once the notification of the new chemical has been successfully completed, there is a compulsory waiting period before the new chemical can be marketed. This is usually 30 days for VIIC and VIIB notifications, and 60 days for VIIA notifications. For the higher tonnage bands, the new chemical can continue to be marketed while the testing is conducted.
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