The CLP Regulation (EC) No 1272/2008 aligns previous EU legislation with the GHS (Globally Harmonized System of Classification and Labelling of Chemicals) ST/SG/AC.10/30/Rev.9, a United Nations system, to identify and inform users about these hazardous chemicals.
It is also connected to the REACH Regulation (EC) No 1907/2006.
This regulation does not cover:
- Radioactive Substances and Mixtures
- Medicines and Certain Medical Devices
- The Transport of Dangerous Goods
Substances and mixtures are classified in specific hazard classes (type of hazard) and categories (level of hazard):
- Physicochemical hazard (e.g. flammable liquid);
- Health hazard (e.g. acute toxicity, carcinogenicity);
- Environmental hazard (e.g. for the ozone layer, aquatic environment).
Substances and mixtures must be labelled with the following information:
- Supplier identity
- Name of the substance or mixture and/or identification number
- Nominal quantity of the product in the package
- Hazard pictograms (graphic designs combining symbols and other visual elements)
- Signal words for the level of hazard (‘Warning’ or ‘Danger’)
- Risk phrases (‘Fire or projection hazard’, ‘Fatal if swallowed’, etc…)
- Safety advice (‘Keep only in original container’, ‘Protect from moisture’, ‘Keep out of reach of children’, etc…)
The packaging of hazardous substances and mixtures must:
- Prevent the contents escaping
- Be made of materials that are resistant when in contact with the contents
- Be strong and solid
- Have sealable fastenings
You can check Tox By Design methodology for Safety Data Sheets, which are duly validated and signed by an European Registered Toxicologist expert.
In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted that ToxBy.Design is duly accredited for the French Research Tax Credit CIR.
Feel free to contact us using the Quotation Request below to receive a quotation for Safety Data Sheet for any Chemicals substances deployed in your GMP manufacturing lines.