Respond to increasingly complex safety and compliance standards
In all markets, particularly health and cosmetics, regulations are constantly evolving. The demands of regulations and the expectations of consumers are increasing when it comes to product safety with respect to humans and the environment. The Regulatory Affairs Department of SEPPIC has three objectives: safety, compliance, and customer support, taking into account market and regional specificities.
An experienced team
The Regulatory Affairs Department of SEPPIC brings together a dozen people, most of whom have worked in other SEPPIC departments: biologists, chemical engineers or toxicologists, researchers. This team also relies on the various professional associations for regulatory watch.
Offer products that are safe and compliant with regulations
The Regulatory Affairs Department ensures the compliance of SEPPIC products with the regulations governing chemicals and with the sector regulations governing the activities of its customers. Assessing the safety of products is essential.
SEPPIC products are classified and labeled according to the classification and labeling regulations implementing the Globally Harmonized System of Classification and Labeling of Chemicals. The safety data sheets, written in more than 50 languages, characterize SEPPIC's commitment to protect workers and the environment.
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The hazardous goods transport safety advisory mission is carried out in-house, ensuring good compliance management in this area.
Lastly, regulations related to the control of chemical substances are fully taken into account. SEPPIC has anticipated the implementation of the European REACH Regulation and has complied with the successive deadlines imposed by this Regulation since its entry into force. In parallel with the European dossiers submitted under the REACH Regulation, SEPPIC also ensures compliance with regulations of the same type outside Europe.
SEPPIC ensures compliance with the specific regulations applicable to its ingredients in the fields of cosmetics, pharmaceuticals, food/feed, industrial applications including detergents and oil drilling.
The customers of SEPPIC benefit from services related to their sector of activity
- Prepare notification and/or market clearance documents for products (e.g., creation and follow-up of DMFs and LoAs for Pharmaceuticals, MF or NDI for Nutrition).
- Prepare product files and make them available to customers (Raw Material IDentification), containing all regulatory and toxicological data.
- Issuance of the conformity certificates required for the use of a product in a country and / or sector.
- Management of applications for voluntary labeling for certain products and markets such as Ecocert, Cosmos, NATRUE, CEFAS / OSPAR, Ecolabel EU, etc.
- Permanent monitoring of regulatory environments to provide customers with marketing advantages related to the regulatory status and the labeling of ingredients in their fields of application.
Toxicology and ecotoxicology
Introduction of new products on the market is supported by appropriate strategies in the areas of toxicology and ecotoxicology.
Assessing the safety of SEPPIC products
- Safety of products on the market via the evaluation of their danger to human health and the environment.
- Regulatory files (in particular for REACH): assessment of the danger and risk to human health and the environment for the substances on file.
- Upstream involvement in all research projects to ascertain the toxicological profile of the selected ingredients.
- Customer support to answer questions pertaining to the (eco)toxicity of SEPPIC products.
- Toxicology and regulatory watch on health safety issues
- Strategy for in vitro testing aimed at assessing the sensitivity potential of a new ingredient:
- In-house data base of sensitizing and non-sensitizing ingredients (tests: DPRA, Keratinosens, hCLAT, Sens-Is),
- Strategy for testing products that are difficult to test (lack of solubility, surfactant, etc).
- Development of a test model that seeks to assess the tolerance of ingredients on immature skin for infant application.
The Regulatory Affairs Department relies on an active regulatory watch to anticipate and support regulatory changes and ensure that SEPPIC ingredients remain compliant at all times. Its experts are actively involved in several working groups within professional organizations and also participate in conferences dedicated to different regulatory environments.