Month: July 2022

Commission Regulation (EU) 2022/1181: warning for products containing Formaldehyde releasers modified.

On the 8^th of July 2022, the European Commission published the Commission Regulation (EU) 2022/1181. This publication amends the preamble of Annex V to Regulation (EC) No 1223/2009. The modification lowers the current threshold for labelling formaldehyde from 500 to 10 ppm.

FORMALDEHYDE RELEASERS

Formaldehyde is forbidden by the Cosmetics Regulation (EC) No 1223/2009, is included in Annex II (List of Substances Prohibited in Cosmetic Products), and is classified as a carcinogen (category 1B) and a skin sensitiser (Category 1), according to CLP Regulation (Regulation (EC) No. 1272/2008).

Some preservatives allowed in cosmetic products fulfil their function since they are Formaldehyde releasers, preserving the final cosmetic product. Substances such as DMDM hydantoin, Imidazolidinyl Urea, and Diazolidinyl Urea, commonly used in cosmetic products, are known to release formaldehyde to fulfil a preserving function in the finished product.

Formaldehyde is prohibited in cosmetic products (entry 1577 of Annex II of the Cosmetic Regulation) and cannot be intentionally added, but formaldehyde-releasing substances are permitted, they are listed on Annex V of the Cosmetics Regulation and have to be used within the restrictions given.

According to the previous regulation, these products must be labelled with the warning ‘contains formaldehyde’ when the amount of released formaldehyde was more than 0.05% in the final product, to communicate the presence of the substance and avoid allergic reactions to sensitised customers.

Recently, the SCCS concluded that the present threshold of 0.05% (500 ppm) does not sufficiently protect consumers sensitised to formaldehyde from exposure to free formaldehyde at cosmetic products, and concluded that the threshold should be reduced to 0.001% in order to protect the consumers. This threshold should apply to the final product. This SCCS opinion was adopted by the European Commission with the published Regulation to amend the preamble of Annex V (List of Preservatives Allowed in Cosmetic Products).

COMMISSION REGULATION (EU) 2022/1181

On July 8th, the European Commission published the Regulation (EU) 2022/1181 amending the preamble of Annex V to Regulation (EC) No 1223/2009. This amendment of the Cosmetics Regulation states the following:

“All finished products containing substances which are listed in this Annex and which release formaldehyde shall be labelled with the warning “releases formaldehyde” where the total concentration of formaldehyde released in the finished product exceeds 0,001 % (10 ppm), irrespective of whether the finished product contains one or more substances releasing formaldehyde.”

So, the formaldehyde threshold to be labelled at cosmetic products was lowered as proposed by the SCCS.

IMPORTANT DATES

The EU Commission proposed a transition period of 24 months for the products to be placed on the market and an extension of 24 months to sell the existing stock.

“However, all finished products containing substances referred to in the first subparagraph which comply with Regulation (EC) No 1223/2009 as applicable on 30^th July 2022 may be placed on the Union market until 31^st July 2024 and be made available on the Union market until 31 July 2026.”

Any affected product must be revised and the brands must ensure that products comply with this amendment. Products in compliance with the old regulation can be placed on the market until July 2024, and these products can remain on the shelves since July 2026.

At this moment, there is currently no equivalent change planned to the UK Cosmetics Regulation, however, this regulation will be implemented in Northern Ireland, as being part of the EU.

The Cosmeservice team is at your disposal, if you wish to get more information about this subject feel free to contact us at info@cosmeservice.com.

For other updates and news please visit www.cosmeservice.com.

 

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REFERENCES:

• Commission Regulation (EU) 2022/1181 amending the preamble of Annex V to Regulation (EC) No 1223/2009.
• Scientific Committee on Consumer Safety (SCCS). Scientific Advice on the threshold for the warning ‘contains formaldehyde’ in Annex V, preamble point 2 for formaldehyde-releasing substances. SCCS/1632/21. 2021.
• Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
• Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures.

Commission Regulation (EU) 2022/1176: Changes in the limits of use of Benzophenone-3 and Octocrylene.

On the 7th of July 2022, the European Commission published an amendment to the EU Cosmetics Regulation, amending Annex VI, the list of UV filters allowed in cosmetic products. The modification applies some changes in the limits of use of Benzophenone-3 and Octocrylene.

Benzophenone-3 and Octocrylene were analysed by the Scientific Committee on Consumer Safety (SCCS) suspected of having endocrine-disrupting properties. Hence, the SCCS evaluated them and released their opinions in March 2021 — SCCS 1625/20 and SCCS 1627/21.

The amendment of the Regulation aims to implement the SCCS’ findings in the EU cosmetics regulatory framework.

 Benzophenone-3

Benzophenone-3 (CAS 131-57-7) is an organic compound used as a UV filter in cosmetic products up to a maximum concentration of 6% and up to 0.5% to protect the cosmetic formulation.

According to the amendment, Benzophenone-3 will remain as follows, the entry of Annex VI will be modified to match the new SCCS concentrations:

• Up to 6% in face, hand, and lip products, excluding propellant and pump spray products.
• Up to 2.2% in body products, including propellant and pump spray products.
• Up to 0.5% in other products.

If used at 0.5% to protect the product formulation, the levels used as UV filter must not exceed 5.5% for face products, hand products, and lip products and the levels used as UV filter must not exceed 1.7% when used for body products.

As stated in the Regulation already, when the substance is present in a concentration higher than 0.5%, the warning ‘contains Benzopenone-3’ must be affixed on the label of the cosmetic product.

 Octocrylene

Octocrylene (CAS 6197-30-4) is an organic substance used as a UV filter in cosmetic products. Also, it is used as a light stabilizer.

Currently, it is allowed to use Octocrylene as a UV filter up to a maximum concentration of 10% in finished cosmetic products. Now, the amendment modifies the concentration depending on the presentation of the product:

• Up to 9% in propellent spray products.
• Up to 10% in other products.

 Dates of applicability

The European Commission allows the companies a one-year period to adapt to the new requirements, as brands will need to reformulate their products.

Therefore, the Regulation amending Annex VI will enter into force on 28th July 2022, after 20 days from its publication in the Official Journal of the European Union.

From that moment, cosmetic products containing Benzophenone-3 and Octocrylene in concentrations in compliance with the old restrictions can still be placed on the EU market, until 23rd January 2023, and the products will have six months more, until 28th July 2023 to be made available on the EU market.

From 28th July 2023, non-compliant products must be withdrawn from the market.

Please, contact us if you need more information, we can help you. Write us an email at info@cosmeservice.com. The Cosmeservice team will be glad to be in touch with you!

You can also have a look at our website to keep updated on the last changes, please visit www.comseservice.com

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 References:

• COMMISSION REGULATION (EU) 2022/1176 of 7 July 2022 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of certain UV filters in cosmetic products. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R1176&from=EN
• REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32009R1223&qid=1657631728773

Regulation (EU) 2022/692, the newest addition to the CLP Regulation. ATP 18.

EU has published the ATP 18, the newest addition to the CLP Regulation on Substances and Mixtures.

European Union (EU) issued Regulation (EU) 2022/692 on May 3, 2022 to amend Regulation (EC) 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures (CLP Regulation, consolidated version to March 2022).

This last amendment is the eighteenth adaptation to technical and scientific progress (ATP-18) to the CLP Regulation and contains changes to the list of chemicals falling under Annex VI to the CLP Regulation.

The revision contains changes to Table 3 of Part 3 under Annex VI ‘List of Harmonized Classification and Labelling of Hazardous Substances.

It adds 39 new entries, including two dibutyltin analogues, bisphenol S (BPS) as a reprotoxic category 1B substance, benzophenone as a carcinogenic category 1 B substance and melamine as a carcinogenic category 2 substance, replaces 17 entries, including bisphenol A (index no 604-030-00-0) with additional classification and labelling information, and deletes 1,5-naphthylene diisocyanate (Index No 615-007-00-X).

What is going to happen?

This publication involves a total of 12 substances that can be used in cosmetics, including six with CMR 1 or 2 classification, which ultimately threatens their use in cosmetic products.

CMR1-Classified substances:

• Benzophenone CAS no: 119-61-9 – Hazard Class and Category code: Carc. 1B
• Theophylline CAS no: 58-55-9 – Hazard Class and Category code: Repr. 1B
• Pentasodium Pentetate CAS no: 140-01-2 – Hazard Class and Category code: Repr. 1B
• Pentetic Acid CAS no: 67-43-6 – Hazard Class and Category code: Repr. 1B

CMR2-Classified substances

• Melamine CAS no: 108-78-1 – Hazard Class and Category code: Carc. 2
• Azadirachta Seed Extracts CAS no: 84696-25-3 – Hazard Class and Category code: Repr. 2
• Trimethylolpropane Triacrylate CAS no: 15625-89-5 – Hazard Class and Category code: Carc.2

This document, Regulation (EU) 2022/692 will become effective on 1^st December 2023 and substances and mixtures classified, labelled and packaged in accordance with this revision should comply before this date.

Therefore, CMR substances, of category 1, under Part 3 of Annex VI to Regulation (EC) No 1272/2008, shall be directly prohibited. What is more, the CMR substances, of category 2, shall be either directly prohibited or may be allowed where the substance has been evaluated by the SCCS and found safe for use in cosmetic products.

Cosmeservice is committed to providing information about the development of regulations for cosmetic products as our core services. Through a deep and periodic research, Cosmeservice provides a wide range of services including analytical testing, dermatological testing and consultancy work, applicable to a comprehensive range of cosmetic products.

Contact us for more information at info@cosmeservice.com or visit our website, we will be glad to help you.

You can find the Regulation (EU) 2022/692 on May 3, 2022 here.

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