Amendments and modifications to the REACH and CLP regulation are gradually introducing increased requirements for the format and content of the SDS. It requires companies to plan an implementation process to ensure compliance with legislative requirements.
Key Obligations and Changes for Chemical Mixture Suppliers under REACH Regulation and Annex II
Each supplier of chemical mixtures must fulfil obligations under Article 31 of REACH (Requirements for safety data sheets) and Annex II of REACH regulation. The references to the legal text have been updated to reflect the latest version of Annex II (i.e. the Annex to Regulation (EU) 2020/878).
The Commission Regulation (EU) 2020/878 introduces changes in the scope of: new requirements for nanoforms of substances, adapting to the 6th and 7th revision of the GHS, and adding requirements regarding the Unique Formula Identifier (as set by Annex VIII to Regulation (EC) 1272/2008), endocrine disrupting properties, specific concentration limits, M-factors and acute toxicity estimates.
The document provides for changes in the provisions and the format of the safety data sheet. The most important changes include:
- new format for section 9
- separation of a new subsection 11.2
- separation of new subsections 12.6 and 12.7
- the wording of the subsection has been changed in sections 14.1 and 14.7
Transition Period and New Requirements for Safety Data Sheets: Compliance and Changes
New requirements for Safety Data Sheet shall apply from 1 January 2021, but in accordance with Article 2 of Regulation (EU) 2020/878, safety data sheets compiled in accordance with Regulation (EC) No 1907/2006 as amended by Commission Regulation (EU) 2015/830, can continue to be used until 31 December 2022. All safety data sheets provided after 31 December 2022 have to be in the format according to Regulation (EU) 2020/878.
This is without prejudice to the obligation to update the safety data sheets in accordance with Article 31(9) of Regulation (EC) No 1907/2006, and to the cases where the Unique Formula Identifier (UFI) is added to safety data sheets as provided for in section 5 of Part A of Annex VIII to Regulation (EC) No 1272/2008 (CLP). https://ekotox.eu/news/ufi-codes-new-duties-from-january-2021/
Amendments to Hazard Classes and Criteria: EU Regulation 2023/707 for Classification, Labelling, and Packaging of Chemical Substances and Mixtures
COMMISSION DELEGATED REGULATION (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures
The European Commission has published a Delegated Regulation amending CLP Regulation, which sets out new hazard classes and criteria for the classification, labelling and packaging of substances and mixtures.
It applies to all chemical substances and mixtures placed on the EU market under REACH. It also applies to active substances in biocidal products and plant protection products, which are normally prioritised for harmonised classification in the EU.
This EU legislation is binding to manufacturers, importers, downstream users and distributors placing substances on the European Union market. Member States will also refer to the new hazard classes and criteria when making proposals for harmonised classification and labelling.
The new hazard classes are:
- ED HH in Category 1 and Category 2 (Endocrine disruption for human health)
- ED ENV in Category 1 and Category 2 (Endocrine disruption for the environment)
- PBT (persistent, bioaccumulative, toxic), vPvB (very persistent, very bioaccumulative)
- PMT (persistent, mobile, toxic), vPvM (very persistent, very mobile)
Implementation of New Hazard Classification and Labelling Rules
The new rules are in force as of 20 April 2023. From this day on, the Member States can make proposals for harmonised classification and labelling (CLH) with the new hazard classes and manufacturers, importers, downstream users and distributors can self-classify their substances and mixtures accordingly.
Transitional periods follow Delegated Regulation’s start. During these, entities like manufacturers, importers, and distributors aren’t obliged to reclassify substances yet. During these periods, the new hazard classes can be applied on a voluntary basis.
At the end of the transitional periods, all manufacturers, importers, downstream users and distributors must apply the new hazard classes.
How to prepare for changes:
– Verification of the company’s profile and position in the supply chain.
Where there is a chain of supply, the requirements of REACH in relation to the provision of safety data sheets apply at each stage of the supply chain. Each entity from the chemical industry: producers, suppliers of substances, mixtures, products for professional use or finished products, especially detergents and biocides, as well as professional workers, shops and retailers have to ensure that they are required to prepare, share and keep safety data sheets.
– Identification of all substances, mixtures and products produced, supplied and used in the company.
The supplier of a substance or a preparation shall provide the recipient of the substance or preparation with a safety data sheet compiled in accordance with Annex II:
(a) where a substance or preparation meets the criteria for classification as dangerous in accordance with Directives 67/548/EEC or 1999/45/EC; or
(b) where a substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII; or
(c) where a substance is included in the list established in accordance with Article 59(1) for reasons other than those referred to in points (a) and (b).
– Analysis of possessed documents and resources.
Start with a well-designed action plan to implement the legislative requirements efficiently. A typical action plan includes the following steps:
STEP 1: Start with Ekotox REACH + SDS Screening – it allows you to identify your company’s profile, identify all chemical substances, mixtures and products, prepare list of chemicals needed SDS and identify gaps in your chemical documentation.
STEP 2: Estimate the time needed for changes and determine the total cost. Devise a change-adaptation plan. Factor in transition opportunities, even if changes are partial.
STEP 3: Contact suppliers and partners for required info to meet obligations due to new legal changes. Gather substance registration numbers, current toxicological data, DNEL, PNEC values, and info on endocrine disruption.
STEP 4: Update your chemical documentation and prepare new Safety Data Sheets in the format specified by Regulation (EU) 2020/878. Produce these sheets in the official languages required by the Member States where you are marketing the product. Remember that a competent individual should be responsible for preparing the safety data sheet. Ekotox Centers provides you with SDS consultancy and the service of preparing safety data sheets in many languages. We offer a discount on the entire volume of your SDS.
STEP 5: Ensure timely distribution of updated SDSs. Keep documents in new format to comply with regulations.
– Setting the schedule and priorities.
There is no one-size-fits-all solution for every company. It depends on the amount of products that the company have in portfolio and that are subject to REACH requirements. For manufacturers with substance dossiers, implementing changes is swifter and simpler. If the company is an importer or downstream user must cooperate with other entities. For non-EU suppliers it will be more difficult and time consuming to obtain the required information and substance dossier. In time it should be considered whether there are no other issues for updating SDS before 31/12/2022, e.g. substance reclassification, updating toxicological information, etc. https://ekotox.eu/update-of-safety-data-sheet/