The new EU chemicals legislation applies to all industrial sectors involved in the handling of chemicals as well as the entire supply chain. It makes companies responsible for the safety of the chemicals they place on the market.
The REACH regulation n ° 1907/2006 relating to the registration, evaluation, restriction and authorization of chemical substances aims to better protect human health and the environment against the risks associated with chemical substances, while promoting the competitiveness of the EU chemical industry.
- Do you manufacture or import chemicals?
- Do you manufacture or import consumer goods?
- Do you use chemicals?
Our ATOUT REACH service supports you in meeting your regulatory obligations
The Biocidal Products Regulation (BPR) No 528/2012 concerns the placing on the market and the use of biocidal products. It aims to improve the functioning of the market for biocidal products and treated articles in the EU, while ensuring a high level of protection of human health and the environment.
- Are you marketing a biocidal active substance?
- Are you marketing a biocidal product?
- Do you manufacture or import an article treated with a biocide?
Our ATOUT BIOCIDES service supports you in meeting your regulatory obligations
According to Article 45 of the CLP Regulation, marketers of certain hazardous mixtures must provide information to designated national bodies. This information is then used by poison control centers. Regulation 2017/542 introduces a harmonized format for the submission of information and a unique formulation identifier (UFI). Take stock of your obligations.
- Do you want to classify your mixtures?
- Do you plan to get your points on your obligations?
- Do you want to check the compliance of your SDS?
Our ATOUT CLP/ FDS service supports you in meeting your regulatory obligations
Directive 2001/83 / EC, amended by Directive 2004/27 / EC, requires the environmental impact to be taken into account in the benefit / risk balance for the evaluation of medicinal products. For pharmaceuticals for human use, an environmental risk assessment (ERA or ERA) is required (or needs to be updated).
- Do you want to apply for a Marketing Authorization (MA) for a drug?
- Do you want to add a new indication, which could lead to a foreseeable increase in environmental exposure?
Our ATOUT PHARMA service supports you in meeting your regulatory obligations
CHEMICAL SUPPLY CHAIN ACCORDING TO REGULATIONS
THE SAME ACTOR MAY HAVE DIFFERENT ROLES DEPENDING ON THE LEGISLATIONS GOVERNING ITS ACTIVITIES:
- REACH: Manufacturer, Importer, Distributor, Formulator, Downstream Users, Industrial End User, Professional End User, Consumer
- CLP: Manufacturer, Importer, Distributor, Formulator, Industrial end user, Professional end user, Consumer
- BPR: SA (approved) or extra EEE biocidal product supplier, Representative, (approved) supplier of active substance or biocidal product, Distributor, Industrial / pro / general public end user, Marketing authorization holder (AMM)
How to determine its obligations? They are associated with the location of the company (in the EEA or not), its role (manufacture, mixing, distribution or placing on the market) and various parameters linked to its activity (tonnages, substances concerned. , articles or mixtures, etc.). Do not hesitate to contact our experts for a quick and free diagnosis.