Two of the current major drivers for safety data sheet (SDS) updates in the EU are:
The update to the Registration, Evaluation and Authorisation of Chemicals (REACH) Regulation (EC) No 1907/2006 Annex II, as per regulation 2020/878, came into effect on 1 January 2021.
It outlines the mandatory format for an SDS and details the information which must be contained within it. All new EU SDSs authored after 1 January 2021 should comply with the amendment. Watch the short video below to understand the changes REACH Annex II has introduced.
What happens to SDSs authored before January 2021?
Any EU SDS compiled according to the old Annex II requirements requires changes to comply with the updated REACH Annex II 2020/878 requirements. The grace period to update these SDSs has now passed. If you haven't already updated your SDSs, please contact us urgently so we can support you in getting these updated as soon as possible.
Who needs to comply with REACH Annex II?
If an organisation wishes to import or place hazardous products on the EU market, they will need to create SDSs under the REACH Annex II guidelines. Some Member States require additional information to be included in the SDS for a product to be placed on the market in that Member State, for example, Germany requires the German Water hazard class to be added to any product in Germany. SDSs in Northern Ireland must comply with EU chemical law and will require updating.
Great Britain (GB) however will not be proceeding with the REACH Annex II update, meaning that products in GB do not require updating to the SDS 2020/878 regulation. Strictly speaking, this means that one SDS will not be compliant for both UK REACH and EU REACH. However, our experts at NCEC expect that the Health and Safety Executive (HSE) may well accept either version. Having an up to date SDS is key, and we recommend that our customers review and update their SDSs immediately. If you are a manufacturer or importer of chemical substances in Great Britain it is critical that you plan to ensure that your SDSs are compliant.
What changes have been introduced by the update to REACH Annex II?
Changes need to be made to several sections of the SDS. A SDS must include all 16 sections and subsections as set out by REACH Annex II.
You can read more about these changes here.
The European Commission makes frequent updates to the harmonised classification and labelling of hazardous substances, through ATP. This is part of the classification, labelling and packaging (CLP) Regulation (EC) No 1272/2008 and is legally binding across Member States. All updates must be communicated on the SDS and on the labelling to maintain compliance.
ATP updates may include changes to:
- Hazard Class and Category Code(s).
- Hazard Statement Code(s).
- Signal Word Code(s).
- Supplementary Hazard statement Code(s).
When this comes into effect, all products containing updated substances must have their labels and SDSs updated to reflect this.
Examples of ATP changes
In ATP 15, there is a new inclusion of Silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1), with EC number (206-991-8) and the hazard statement of H350i (may cause cancer by inhalation). This means that uses of these chemicals would need to include this information on any associated labels and SDSs from March 2022.
Nitric acid with EC number (231-714-2) has the hazard classes and categories of oxidizing liquids and skin corrosion 1A on ATP 14 and ATP 15, but the latter includes the additional class acute toxicity 1. Thus, any associated labels and SDSs would need to have an amendment to include Skin Corrosion 1A to its hazard class and category from March 2022, to ensure compliance with CLP.
How can NCEC help?
NCEC strongly recommends that chemical suppliers begin the process of updating their SDSs as soon as possible so that they remain compliant with UK REACH and EU REACH, and regularly update their SDSs to remain compliant with changes to ATPs, thus avoiding any disruption to their operations in the future.
NCEC offers the following services to support SDS compliance:
- As your regulatory compliance partner, we offer a bespoke service in which we amend, update and author new SDSs and provide consultancy advice for staying compliant with Annex II, REACH, CLP and ATP.
- We provide SDS health checks to indicate if there are areas of non-compliance within your SDSs and then amend/update these. We ensure consistency with harmonised classifications and regulated databases, as well as with the formatting requirements mandated by European regulation.
- We offer a horizon scanning service which periodically updates you of any regulatory changes that may affect your products.
- We can update any of your current SDSs or poison centre notifications with the correct ATP classifications.
- We also offer a SDS training course that can be tailored to fit you/your regulatory team’s requirements. More details on the course can be found here.
Key benefits of using NCEC’s SDS services:
- Fully outsourced SDS authoring and translation service requires minimal client input/resources, leaving you free to concentrate on running your business operations.
- Multilingual service enables you to submit SDSs in the required local language.
- Expert review and analysis of your SDSs provides reassurance that your documents and their contents are in line with all critical industry regulations.
- A fast and responsive service.
Choosing NCEC to undertake a fully outsourced or support service means you will benefit from our experience, and reduce your time and cost complying with regulatory legislations.
If you require any further assistance regarding SDSs, please contact us using the form at the side or email us at [email protected].