Registration & notification

Regulation (EC) No 1272/2008 regulates the classification, labelling and packaging (CLP) of dangerous substances and mixtures. CLP is legally binding in all member states and directly applicable to all industries. Every manufacturer, importer or downstream user is required to correctly classify, label and package his products before placing them on the market.

In 2017, a new Annex VIII was added to the CLP Regulation to harmonise the information requirements for notification to the poison centres.

Since 2020, these notifications have been done at European level through the ECHA (European Chemicals Agency) portal.

BIG can help your company by doing the notification at European level through the portal.

This authorisation is a specific part of REACH and aims to ensure that Substances of Very High Concern (SVHC) are progressively replaced by less dangerous substances or controlled using appropriate technologies.

If a substance is defined as of very high concern, it will be added to the Candidate List for eventual inclusion in the Authorisation List. Inclusion on the Candidate List leads directly to communication obligations throughout the supply chain. One way to do this is through the Safety Data Sheet (SDS).

For articles, there are a number of additional obligations:

• answer consumer’s queries (art. 33, § 2, REACH)

• notification to ECHA.

BIG can assist your company in complying with SVHC obligations without any problems.

The European Biocidal Products Regulation or BPR (Regulation (EU) No 528/2012) regulates the trade and use of biocidal products to protect humans, animals or materials from harmful organisms such as pests or bacteria through their active substances. The active substances in biocidal products require prior approval at European level (with well-defined exceptions). A national authorisation is then required for each biocide before it is placed on the market. An authorisation can be extended to other EU member states through mutual recognition via a European authorisation (Union authorisation).

BIG can assist your company in the field of BPR in several ways, through advice, case management (from preparation to follow-up), training, and more.

BIG assists manufacturers and importers as well as downstream users of hazardous substances with their legal obligations related to up- or downstream communication.

Our service ranges from registration (preparation/updating of technical dossier (IUCLID 6) and chemical safety report (CSR)) to notification in case of presence of substances of very high concern in articles (SVHC), the downstream user report in case of non-conformity of an ES, and so on.

Regulation (EU) No 649/2012 on Prior Informed Consent regulates the import and export of certain hazardous chemicals, and imposes obligations on companies wishing to export them to countries outside the EU.

The PIC regulation, which is based on the Rotterdam Convention, applies to chemicals that are banned or severely restricted: industrial chemicals, pesticides and biocides - the specific substances are listed in Annex I of the regulation.

Through the European Chemicals Agency's (ECHA) ePIC platform, exporters can submit export notifications and request prior consents from importing countries. They are then assigned a reference identification number (RIN), which is checked by customs upon import and export of the respective substance.

BIG can take care of the following aspects of PIC for your company:

• determine whether a substance falls under PIC and what specific obligations are associated with it

• arrange and follow up all corresponding notifications to ECHA