EU inspections to control safety data sheets (SDS) in the EU-wide enforcement project in 2023
The EU-wide enforcement project (REF-11) in 2023 will look at the quality of information in safety data sheets.
SDS – Safety data sheets are the main vehicles for communicating safety information in the supply chain. If they are deficient, workers and professionals may not receive adequate information to use hazardous substances and mixtures safely.
The poor quality of information in safety data sheets is a long-standing issue detected also in many earlier enforcement projects – up to 52 % were found to be deficient in the Forum’s REF-2 project in 2013. Experience from enforcement activities in Member States confirms that the issue persists.
SDSs quality
The project will check compliance with the revised requirements under Annex II. to REACH, which sets the content and format required for safety data sheets. With the revised requirements entering into force in 2023, this is a timely opportunity to have a harmonised project to check that companies across the EU are fulfilling this duty.
Any SDSs that were compiled according to the old Annex II requirements will have to be rewritten to comply with the updated requirements by 31 December 2022.
The European Commission published their proposal for CLP Regulation on the 19th December.
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND. OF THE COUNCIL amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council
on classification, labelling and packaging of substances and mixtures.
As part of the CLP Regulation revision package, a delegated act will add definitions and scientific and technical criteria to enable substances and mixtures that have endocrine disrupting. (‘ED’), persistent, bioaccumulative and toxic (‘PBT’), very persistent and very bioaccumulative (‘vPvB’), persistent, mobile and toxic (‘PMT’), or very persistent and very mobile (‘vPvM’) properties to be classified into established hazard classes.
The impact of adding these new hazard classes has been assessed as part of the overall impact assessment on the revision of the CLP Regulation.
The CLP Regulation revision package aims to:
(i) ensure that all hazardous chemicals, including those with ED, PBT, vPvB, PMT and vPvM. properties, are classified adequately and uniformly throughout the EU;
(ii) improve the efficiency of hazard communication by making labels more accessible and. understandable for users of chemicals, and provide companies with more flexibility, thereby reducing the administrative burden without lowering safety levels;
(iii) make sure that the rules on chemical hazard classification and communication. are applied by all relevant actors in the supply chain.
POPs – Persistent Organic Pollutants – REGULATION (EU) 2022/2400 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 23 November 2022
amending Annexes IV and V to Regulation (EU) 2019/1021 on persistent organic pollutants
Member States plan to evaluate 24 substances in 2023-2025
Corap: 24 substances were listed for evaluation by EU Member States under the Community rolling action plan (CoRAP) for 2023-2025.
Five are planned to be evaluated in 2023, with 19 listed for evaluation in 2024 and 2025.
Corap 2023-2023 substances are:
2-Propenoic acid, methyl ester, reaction products with mixed O,Obis(branched and linear pentyl and iso-Bu) phosphorodithioates
Butanoic acid, 4-amino-4-oxosulfo-, N-coco alkyl derivs., monosodium salts, compds. with triethanolamine
tert-butylphenyldiphenyl phosphate (tBuTPP)
N-methylaniline
Sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate
3,3′-[methylenebis(oxymethylene)]bisheptane
1,3-diisopropylbenzene
1,4-diisopropylbenzene
Dioctyltin oxide
Bis(2,6-diisopropylphenyl) carbodiimide
Tris[2-chloro-1-(chloromethyl)ethyl] phosphate
A mixture of: triphenylthiophosphate and tertiary butylated phenyl derivatives
Reaction mass of 1,3-diisopropylbenzene and 1,4-diisopropylbenzene
Benzaldehyde
α-trimethylsilanyl-ω-trimethylsiloxypoly[oxy(methyl-3-(2-(2-methoxypropoxy)propoxy)propylsilanediyl]-co-oxy(dimethylsilane))
Acrylic acid, monoester with propane-1,2-diol
Octene, hydroformylation products, low-boiling
Diethyl Ether
Sodium hydroxymethanesulphinate
Carbon black
4,4′-Isopropylidenediphenol, ethoxylated
Betaines, C12-14 (even numbered)-alkyldimethyl
5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, reaction products with 1-nonanol
4-(4-isopropoxyphenylsulfonyl)phenol
2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
Sodium 3-nitrobenzene sulphonate
4,4′-methylene bis(dibutyldithiocarbamate)
Propyl acetate
Oxirane, mono[(C12-14-alkyloxy)methyl] derivs
In May 2021, the European Commission asked ECHA for an opinion on the comparative assessment of anticoagulant and antivitamin rodenticides. These agents work by interfering with the activation of vitamin K and blood clotting, thereby causing the internal bleeding.
At the last meeting, the Biocidal Products Committee. (BPC) concluded that, due to the identified risk to the environment and human health, these agents should be. handled with care.
Based on the studies carried out, the BPC Committee concluded that mechanical rodent traps are effective enough to control mice indoors. He also cited carbon dioxide as a safer chemical alternative, which when used by trained professionals has a much lower overall hazard profile.
Based on the opinion of the BPC Committee, the European Commission will prepare its decision. It is also expected that Member States and biocidal authorization authorities will be provided with appropriate instructions on how to authorize anticoagulant rodenticides.
In 2016, the competent French authority submitted to the European Chemicals Agency. a proposal to classify titanium dioxide as a carcinogenic substance. The following year, EU Commission adopted Regulation 2020/2017 (14 ATP to CLP) as a consequence of RAC opinion. classifying titanium dioxide as a category 2 carcinogen.
Chemical entities brought actions before the General Court for the partial annulment of Regulation 2020/217. In the judgment, the Court annuls the contested regulation in so far as it concerns the harmonised classification and labelling of titanium dioxide. in the form of a powder with 1% or more of particles with an aerodynamic diameter not exceeding 10 μm.
The General Court recognised that RAC committed. a manifest error of the assessment and found that the contested classification and labelling infringed the criterion according to which the classification of a substance as carcinogenic can apply only to a substance that has the intrinsic property to cause cancer.
This decision is very important for the industry, because titanium dioxide is commonly used in the production of paints and coatings, plastics, paper, as well as in the cosmetics industry for sunscreen cosmetics. It can be found in paper, cosmetics, medicines, medical supplies and food products.
We encourage you to read the current issue of EkotoxInfo chemical news. In the summary of last month you will find the following topics:
One in four substances recovered from waste non-compliant with REACH
Restriction proposals for bisphenols and creosote available
Assessment of regulatory needs reports published
Restriction process on certain cobalt compounds terminated
Consultation on new CLP classes finalised
Skin sensitizing substances in consumer mixtures
Control program of imported substances and products in 2023-2025
SCIP database available in EEA countries
Revision of REACH regulation to be postponed
Cosmetics – changes in the cosmetics ingredients
The European Commission has published guidelines for safe chemicals
Community rolling action plan for 2021-2023
A new list of allergens in cosmetics in 2023
Guidance on the Biocidal Products efficacy has been updated
Reminder to update the safety data sheets
One in four substances recovered from waste non-compliant with REACH
ECHA checked whether substances obtained from waste meet the conditions for exempting substance registration under REACH. The obtained results showed that 26% of the substances did not meet the conditions in the scope of:
the identity of the recovered substance with the original one, registered in REACH;
Restriction proposals for bisphenols and creosote available
Restriction proposals published for:
4,4′-isopropylidenediphenol (bisphenol A) as well as other bisphenols and bisphenol derivatives with endocrine-disrupting properties for the environment, prepared by Germany;
The proposed restriction of some cobalt compounds has temporarily not been adopted. According to the April decision, the committee should not prepare amendments to Annex XVII of REACH. However, the Commission asked the RAC for an opinion on the occupational exposure limits to cobalt compounds, due by the end of this year.
Open public consultations on the draft law introducing new hazard classes as part of the revision of the CLP regulation lasted until October 18, in which the committee proposed the need to introduce 3 new hazard classes. The Commission will now assess the comments on the project and start the procedure for adopting the changes.
Denmark, France, Germany and Ireland were requesting interested parties to submit information related to skin sensitising substances in consumer mixtures. The information gathered will be used to assess the need for regulatory actions on skin sensitisers in consumer mixtures.
This call for evidence consultation has been extended until 31 October 2022.
Control program of imported substances and products in 2023-2025
The inspections are planned for 2023-2025 and involve the national authorities of the Member States. The project will also work on further developing and strengthening the existing cooperation between REACH inspectors and customs authorities.
From 7 November, companies from Iceland, Liechtenstein and Norway can submit notifications on their products containing substances of very high concern to ECHA. We remind you, that for EU countries, the duty to submit SCIP notifications started in January 2021.
On October 18, 2022, the European Commission adopted the Commission’s Work Program for 2023, postponing the revision of the REACH Regulation to the end of 2023.
On November 10, the European Commission published a new regulation amending the annexes to the Cosmetics Regulation. This regulation shall enter into force on the twentieth day following its publication – 01.12.2022.
The European Commission has published guidelines for safe chemicals
The Strategic Research and Innovation Plan for Chemicals (SRIP) sets out a roadmap to the European Green Deal and highlights the key areas of research and innovation responsible for creating safe and sustainable chemicals and materials.
The Community rolling action plan identifies priority substances for evaluation to address concerns about possible risks to human health or the environment from the manufacture or use of these substances. The assessment may lead to the inclusion of a substance e.g. on the CMR, ED, PBT list and regulate their further use.
The amendment to the Cosmetics Regulation extends the list of allergenic substances. The project is already prepared and its publication is planned at the turn of the first / second quarter of 2023.
Guidance on the Biocidal Products efficacy has been updated
The guidance document for the Biocidal Products Regulation (BPR) Volume II – Efficacy Assessment and Evaluation (Parts B+C) has been updated. The update covers the chapter on disinfectants for product-types 1-5. Appendices 1-4 have also been updated based on recently developed and published European standards.
Once again, we would like to remind you about the upcoming update date of the current safety data sheets. From January 1, 2023, all safet data sheets must comply with the new format.
EKOTOX CENTERS specializes in authoring of safety data sheets based on the requirements of the CLP and REACH Regulations + additional requirements of the EU member state. The documents must be drawn up by a competent person with appropriate knowledge and training, taking into account specific requirements of the respective EU Member State starting including languages, occupational limit values, national toxicological centre notification and more.
But, be careful, just „translation” of a safety data sheet document drawn up by an ordinary translator who has no knowledge of chemicals legislation could not be in compliance due to specific legal terms so it is often drawn up by translations that are too literal, erroneous and not in accordance with the European guidelines for drawing up safety data sheets. More to that, safety data sheet is today more complex and so multidisciplinary team will definitely be of an advantage.
Our specialists have many years of experience and daily working on different aspects of EU chemicals legislation, including: classification of chemical substances and mixtures, assigning H and P phrases, rules of labelling and packaging of substances and mixtures, notifications in the Poison Centre, assigning UFI codes, advising in labelling, managing the safety of documentation.
Language(s) in which the SDS must be provided:
According to REACH Article 31(5), “The safety data sheet shall be supplied in an official language of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide otherwise”.
It should be noted that it is for the recipient Member State (MS) to provide otherwise – i.e. for example the existence of an exemption in the MS of manufacture does not give an exemption in a different MS where the substance or mixture is placed on the market. Even if the MS provides otherwise, it may be desirable to always provide (potentially in addition) the SDS in the language of the country.
It should be noted that certain Member States require that the SDS be provided in additional official MS languages (of that MS, where there is more than one official language).
It should also be noted that as the annexed exposure scenario is considered to be an integral part of the SDS it is subject to the same translation requirements as the SDS itself – i.e. it must be supplied in an official language of the Member State(s) where the substance or mixture is placed on the market, unless the recipient Member State(s) concerned provide otherwise.
SDS – New requirements 2022
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.
SDS changes:
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;
Countries and languages of SDSs:
EKOTOX CENTERS offer SDS authoring for a wide range EU member states and other countries, basically in the following languages:
EU countries
Austria – German;
Belgium – French/German/Dutch;
Bulgaria – Bulgarian;
Croatia – Croatian;
Cyprus – Greek;
Czech Republic – Czech;
Denmark – Danish;
Estonia – Estonian;
Finland – Finnish;
France – French;
Germany – German;
Greece – Greek;
Hungary – Hungarian;
Iceland – Icelandic;
Italy – Italian;
Latvia – Latvian;
Lichtenstein – German;
Lithuania – Lithuanian;
Luxemburg – French;
Malta – English;
Netherlands – Dutch;
Norway – Norwegian;
Poland – Polish;
Portugal – Portuguese;
Romania – Romanian;
Slovakia – Slovak;
Slovenia – Slovenian;
Spain – Spanish;
Sweden – Swedish;
NON-EU countries
Switzerland – German/English/Italy/France;
United Kingdom and Ireland – English;
Ukraine – Ukrainian.
If you have not found the appropriate country / language above, please contact us for an individual assessment of the possibility of preparing a required document.
At its last meeting in November, the Enforcement Forum. agreed on a follow-up project to investigate whether companies are complying with. REACH obligations for products imported from outside the EU. Inspections will check the enforcement of regulations for the import of substances, chemical mixtures and articles.
The inspections are planned for 2023-2025 and involve the national authorities of the Member States. The project will also work on further developing and strengthening the existing cooperation between REACH inspectors and customs authorities.
Previous results showed that 23% of the imported products checked were non-compliant with the requirements set out in EU law, so ECHA decided to take appropriate action.
On November 10, the European Commission published a new regulation amending the annexes to the Cosmetics Regulation. The change concerns:
– limitation Butylated Hydroxytoluene (BHT) to a maximum concentration of 0.001% in mouthwash, 0.1% toothpaste and 0.8% in other rinse-off and leave-on products
– limitation of Acid Yellow 3 to 0.5% in non-oxidative hair dye products
– limitation of Homosalate ingredient to 7.43% for face products
– Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine and its nano form – maximum concentration up to 10% and limitation in inhalation exposure
This regulation shall enter into force on the twentieth day following its publication – 01.12.2022.
COMMISSION REGULATION (EU) 2022/2195
of 10 November 2022
amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of Butylated Hydroxytoluene, Acid Yellow 3, Homosalate and HAA299 in cosmetic products and correcting that Regulation as regards the use of Resorcinol in cosmetic products.
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