The EDQM strives to protect public health notably by developing international quality standards for medicines. As much as possible, the use of substances of very high concern is avoided in these quality standards, notably in the European Pharmacopoeia monographs. When they cannot be avoided, the EDQM supplies chemicals that, in some cases, may be of very high concern.

Two types of hazards are assessed by the EDQM for reference standards:

• Chemical hazards: the EDQM voluntarily complies with EC Regulations No 1272/2008 (CLP Regulation) and No 1907/2006 (REACH Regulation). When a hazard is identified according to these regulations, a Safety Data Sheet is made available.
• Biological hazards: the assessment is based on Directive 2000/54/EC. When a hazard is identified according to this document, a Biohazard Statement is made available.

The EDQM does not issue Safety Data Sheets and Biohazard Statements for harmless materials (e.g. some herbals, cotton wool) unless new data arises or an amendment to the legislation later justifies chemical classification.

Safety documentation is provided for occupational health only and is not part of quality standards.

Safety Data Sheets and Biohazard Statements are available on-line in the reference standards database, or upon request via the HelpDesk.

The EDQM SDS are intended solely to provide information on hazards as required by applicable legislation, particularly by Regulations (EC) Nos 1907/2006 (REACH Regulation) and 1272/2008 (CLP Regulation). They must not be used for purposes beyond their defined scope, including determining any characteristics of the substances and mixtures.

As a downstream user, the EDQM relies on classification data provided by raw material suppliers and information from scientific literature to establish SDS. The EDQM does not carry out tests to corroborate these data. Accordingly, while every effort is made to ensure the accuracy of classifications, the information contained in SDS reflects the current state of knowledge and may not be exhaustive. It cannot be excluded that new scientific data may highlight previously unknown risks, resulting in the need for reclassification. Users of EDQM products are solely responsible for evaluating risks in their specific use cases and ensuring compliance with all applicable laws and regulations.

SDS are prepared by the EDQM to assist users and do not represent official classifications by the European Pharmacopoeia Commission or any other organ or body of the EDQM. As such, they do not reflect the position of the States signatures to the European Convention on the Elaboration of the European Pharmacopoeia and cannot be used as official EDQM standards or documents with binding effect.

As safety data are not available for most impurities, such impurities are classified as being at least as dangerous as the related substances.

The Council of Europe (EDQM) accepts no liability for any direct, indirect, incidental, consequential, special, or punitive damages arising from or connected to the SDS or related products, including but not limited to improper handling, misuse, or misinterpretation of the SDS. Users must exercise caution and undertake their own assessments to assess and mitigate risks associated with the use of the products.