French Nanomaterials Mandatory Reporting Scheme
In France it is now mandatory for everyone producing, distributing or importing nanomaterials to declare them to the national authorities. This is an annual declaration that every company, lab or manufacturer must make if they use, produce or even handle more than 100g of nanomaterials per year. The final deadline for 2012 declarations is 1st July 2013, after which the state may fine those companies that do not comply.
The Nano Centre, in association with BREC Solutions, can assist you with the preparation and submission of the notification to the French Authorities.
The declaration of data is managed by Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES - French agency for food safety, the environment and labour). A unique reference is provided to the declaring party after the submission of information. If the nanomaterial is used further in the supply chain this reference should be passed on. Distributors should pass on the reference from manufacturers. Importers should obtain the reference from the manufacturers that should have declared the material already.
Substance at nanoscale used in this regulation follows the article 3 of EC regulation no. 1907/2006. The particles have to be intentionally produced with a minimum proportion of particles in the number size distribution with one or more dimension in the size range of 1nm to 100nm. Aggregates and agglomerates are included. The minimum proportion referred to above was specified more precisely in the Ministerial Order of 6th August 2012 and was defined as 50% of particles by number (neither mass nor volume data can be used).
Schedule and Penalties
At the beginning of the scheme that started on the 1 January 2013 there is a 6 months grace period giving manufacturers and handlers until the 1 July 2013 to declare all activity exceeding 100g per year. On a yearly basis materials should be declared to French authorities before 1st May for the operations conducted in the previous year. If the agency ANSES finds the declaration incomplete the declarer has up to two months to submit all the required information. A party that wishes their declaration to remain confidential must write to Minister of defence within a maximum of 5 days from the date of required declaration. Failing all the deadlines the fine is up to €3000 with daily penalty of €300 from the date of the decision and up to the date of completion of the declaration.
Who is affected
The decree applies to all manufacturers, importers, distributors, professional users, scientific research and development labs as well as product and process development labs. Annual minimum amount of 100g or more per entity should be declared. If the nanomaterial is not placed on the market but is used for research the declaring party could simply declare their identity and sector of use.
Information to be declared
- DP identity and its sites should be declared. This applies to multinationals and research organisations.
- Nanomaterial chemical name, chemical formula, CAS number, EC reference, Commercial name must be declared. Particle mean size, number size distribution, mean size of aggregates and agglomerates, particle shape, description of any coatings and physical state of the final material. All has to be supported with data, and methods used to obtain the data should be specified. Non-mandatory information on REACH number (if dossier exists), impurities, crystalline state of the substance, specific surface area and surface charge should (but does not have to) be supplied by the DP.
- Quantity of nanomaterial expressed in kilograms. Quantity of material is considered to be confidential by default without DP applying for confidentiality derogation to the ministry.
- Planned use of the substance should be declared. The commercial name of the substance and its formulation should be declared, while the latter will be kept confidential by default.
- The identity of professional users and manufacturers up the supply chain is required. This information is also kept confidential without the DP having to ask for confidentiality derogation
Fonte: The Nano Centre