If you are a manufacturer, importer or downstream operating within Spain or France then you should be aware of the upcoming registration deadline for their respective poison centres currently due in the New Year. Compliance with EU Poison Centre regulations can be a complex matter due to the variations of implementation between member states.
Spain and France opted for phased registration of products dependent on hazards classes, with the next phase of registration due by the 1st January 2016. The following is a guide to the classifications that will fall under scope following the Jan 1st deadline for the Spanish and French Poison Centres.
For compliance within Spain, products with the following hazard classes must be registered with the Toxicology Information Service (SIT) before the 1st January 2016 deadline.
- All mixtures that are classified as hazardous due to their effects on human health or their physical effects and are sold to consumers.
Mixtures that fulfill the following classification criteria and are marketed for professional users:
- Acute toxicity (oral, dermal and inhalation), Category 1, 2 and 3 (H300 / H301 / H310 / H311 / H330 / H331)
- Specific Target Organ Toxicity (STOT) for single and repeated exposure, Category 1 and 2 (H370 / H371 / H372 / H373)
- Skin corrosion (H314)
- Eye damage category 1 (H318)
- CMR, Category 1A, 1B and 2 (H340 / H341 / H350 / H351 / H360 / H361).
- Respiratory or skin sensitisation Category 1 (H317 / H334).
For France, in addition to the 1st April 2014 requirements, mixtures with the following hazard classifications fall under scope for submission to the Institut National de Recherche et de Sécurité (INRS) from the 1st January 2016.
- Respiratory sensitization, Category 1 (H334)
- Skin sensitisation, Category 1 (H317)
- Carcinogenicity mixtures, Category 2 (H351)
- Germ cell mutagenicity, Category 2 (H341)
- Reproductive toxicity, Category 2 (H361)
Mixtures placed on the market prior to this date must have their declaration submitted by the 30th of January 2016, or face a €3,750 fine. For products that are new to market or have undergone a change in composition, name, brand, etc. must be declared within 30 days of being placed on the French market. Additionally, it is strongly advised by the INRS that all products are registered with them regardless of classification or use, prior to any regulatory obligation.
Ensuring timely and robust submission to all member states can be a challenge for both domestic and multi-national organisations. If you require any assistance or further information on how to ensure your company is compliant with poison centre requirements then please feel free to contact NCEC for advice. Alternatively, our updated Poison Centre information pack can be accessed here.