Safety Data Sheet is one of the elementary and most useful communication tools in the supply chain, between the supplier/manufacturer and the downstream user. The obligation of compilation of SDS results from the Article 31 of the REACH Regulation [Regulation (EC) No 1907/2006].
The fundamental purpose for compilation of the Safety Data Sheet is to inform the users of potential hazards arising from the contact with dangerous substances or mixtures, methods of the risk minimisation as well as the way of conduct in case any dangerous situation arises.
CLP system contains harmonised criteria for the classification of chemical substances and mixtures regarding the hazards they cause for both, human health and the environment. It also covers the harmonised rules for hazard notification, including the requirements concerning labelling and safety data sheets.
In accordance with the legal requirements, Safety Data Sheet should be compiled by duly qualified persons (with relevant substantial knowledge, among others, in the field of chemistry, law, toxicology etc.).
Moreover, in accordance with the Polish law and in compliance with the provisions of the REACH Regulation, all the safety data sheets used within the territory of Poland, must be prepared in Polish language and include additional Polish legal regulation in that scope.
The responsibility for accurate preparation and placing on the market of a properly, substantially (classification and description of hazards) and formally compiled Safety Data Sheet rests on the manufacturer, his representative, importer or supplier of a given chemical product. Safety Data Sheet should also be updated and completed in accordance with the guidelines included in the Act on Chemical Substances and Mixtures and the Community regulations.
Safety Data Sheet is one of the most important documents applied in the supply chain, in compliance with the REACH Regulation.
From 1 December 2010, safety data sheets must be compiled in accordance with requirements set out in Annex I to the Commission Regulation 453/2010/EC.
Below, please find the most important time periods, indicating changes to safety data sheets, classification and labelling of substance and/ or mixtures, in accordance with the Regulations 1272/2008/EC and 453/2010/EC.
Within the framework of services related to the compilation of safety data sheets, we offer, inter alia: safety data sheet compilation, both, based on the formula and on the original MSDS prepared in any foreign language, as well as compilation of the MSDS in multiple foreign languages, in accordance with the requirements of the Regulation 453/2010/EC. Conducting the classification compliant with the requirements of CLP Regulation (GHS), and in particular:
- compilation of the safety data sheets based on the primary data (formula);
- compilation of the safety data sheets based on the original data sheets compiled in other foreign languages, together with adjusting them to all the specific legal requirements applicable in Poland and in the Community;
- compilation of the safety data sheets, considering the new classification and labelling rules compliant with the CLP Regulation (EC) 1272/2008,
- compilation of the safety data sheets in all official EU languages as well as in non-Community languages (Russian, Ukrainian, Norwegian). At the customer’s request, we can also prepare safety data sheets in other languages;
- evaluation of existing safety data sheets, regarding their compliance with the current regulations followed by the repair programme prepared specifically for your company;
Thanks to the qualified team of experts, representing all the required areas of knowledge, both technical and legal, THETA Doradztwo Techniczne is able to guarantee, that documentation concerning your product shall always be elaborated in a reliable manner and in accordance with applicable regulations – both, UE and national.
Regardless of the obligation concerning the compilation of the Safety Data Sheet, packaging of all the dangerous substances and mixtures should be properly marked and labelled – in accordance not only with the relevant Community requirements, but also with Polish regulations. Moreover, in order to prepare the correctly labelled and marked packaging and label, it is necessary to have suitable knowledge based on the other regulations – both, UE and Polish – concerning the rules and obligations of placing some additional marking on the packaging.
These are, among others:
- Regulations governing placing the marking for the blind and partially sighted (Journal of Laws 2012, item 688 with further amendments);
- Regulations governing the rules for making the child resistant packaging systems (Journal of Laws 2012, item 688 with further amendments);
- Regulations governing some additional obligations concerning marking of the aerosol products (Journal of Laws No 188, item 1460; Journal of Laws 2014 item 345);
- Transport regulations – labelling of packaging in transport (ADR regulations);
- Regulations concerning products in packages (Journal of Laws No 91, item 740 with further amendments. Journal of Laws No 229, item 1495 of 2010);
- Regulations related to recycling of packaging (Journal of Laws No 94, item 927, 94/62/EC);
- and other Polish and EU regulations.
Within the framework of meeting all the requirements related to the appropriate labelling of chemical product packaging regarding its correct marking and labelling, we offer the comprehensive review and compilation of labels as well as relevant guidelines for the packaging labelling, and in particular:
- evaluation of available labelling (labels) of chemical products – all categories – regarding their conformity with the current legal regulations, together with the repair programme tailored to your company’s needs;
- development of new labelling based on the available safety data sheets and/ or data concerning the products;
- update of the existing labelling based on the available safety data sheets and/ or data concerning the products;
- development of new labelling compliant with applicable regulations of CLP Regulation (EC) 1272/2008.
Compilation of the safety data sheet and labelling of the chemical product alone does not exhaust the scope of all the obligations related to placing the chemical product on the Polish market.
THETA Doradztwo Techniczne offers an innovative and verified dossier evaluation programme (audit) combined with the post-audit report and the schedule of relevant corrective measures, which should be implemented. This way, we are able to identify and evaluate all the elements of activity related to safety, that are necessary for adequate preparation of documents, both in accordance with your customers demands and in compliance with the requirements of Polish inspection and control bodies.
Offer – consulting and audits
Audit and consulting in scope of supervision and monitoring of dangerous substances in company, obligation of dossier compilation and contacts with suppliers and customers. Audit – analysis of the company’s needs regarding the obligations of chemical product dossier preparation, notifying suppliers and customers and managing the chemical substances in the company (in accordance with the REACH Regulation) in respect of the European regulations, as well as the specific, Polish legal requirements.
All audits are conducted by qualified auditors, certified as REACH Internal Auditors by the accreditation body RW TÜV NORD.
- monitoring and notifying of changes to the regulations in scope of regulations regarding marketing of chemical products (EU and Polish), significant for the company;
- support in interpretation of regulations concerning placing of chemical substances on the market;
- preparation of letters and interpretations for customers, suppliers and control bodies based on the provisions of REACH, CLP and the Act of chemical substances and their mixtures (Journal of Laws No 63, item 322 with further amendments).
Thanks to the qualified team of experts, representing all the required areas of knowledge, both technical and legal, THETA Doradztwo Techniczne is able to provide the appropriate compilation of safety data sheets, as well as preparation of labelling for chemical products.
