European Union (EU) countries are required to set up appointed bodies called as poison centers (PCs). These centers receive information on the composition of hazardous materials, substances, and mixtures such as detergents, paints, adhesives etc.
Under the classification labeling and packaging (CLP) regulations of the EU, the manufacturers or producers, the importers or formulators, distributors, and downstream users, who wish to place hazardous mixtures (such a detergents, paints, household chemicals) classified as hazardous on the basis of their health or physical effects on the EU market have direct responsibility to submit Poison center notifications (PCN).
Depending on the EU country, physicians, professional users and consumers can contact these appointed bodies known as poison centers (PCs) to get recommendations for medical treatment in cases of poisoning. According to the information, these centers answer at least 600,000 calls per year from general public or physicians. There are some accidental cases that involve exposures to children and fatalities.
Submission Exemption of PCN
The following mixtures are exempt from the submission of PCN under CLP regulation.
- Radio-active substances and mixtures
- Mixtures for R&D use
- Certain mixtures in finished state intended for final user: medicinal products, cosmetics, medical devices, food, etc.
In addition, mixtures only classified with gases under pressure or/and explosives under CLP regulation are exempt from PCN. (For hazardous mixtures which are not subject to submission obligations (i.e., mixtures with environmental hazards only), submission may be done on a voluntary basis).
Importers and downstream users placing hazardous mixtures on the market not notified already under national legislation must comply with the new PCN requirements from the following dates:
Mixture for consumer use: January 1, 2020
Mixture for professional use: January 1, 2021
Mixture for industrial use: January, 2024
(By January 2025, a submission must be made for all mixtures on the market according to the harmonized Annex VIII requirements in CLP regulation).
Information Needed for Submission
Identification of mixture and submitter: For mixture, unique formula identifier (UFI), product category and product name must be provided.
Hazard identification and additional information: This includes hazard classification, label elements, available toxicological information, physical state and size etc.
Information on mixture components: Ideally, the full composition of the mixture should be indicated. Nevertheless, components do not legally need to be indicated when present in the mixture below certain concentration thresholds. Furthermore, if a mixture is for industrial use only, a limited submission is made. The information on composition may be limited to the information available in Safety Data Sheets (SDSs). For hazardous components which must be listed, identity and exact concentration or concentration range must be provided.
For further information and implication of CLP rule and regulation visit web pages of ECHA and PC.
- European Chemical Agency, web page at: https://echa.europa.eu/
- COMMISSION REGULATION (EU) 2017/542 of 22 March 2017, web Page at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0542&from=EN.
- Poison Centers- EU, web page at: https://poisoncentres.echa.europa.eu/appointed-bodies
- Article 45: Appointment of bodies responsible for receiving information relating to emergency health response, web Page at: https://reachonline.eu/clp/en/title-vi-article-45.html.