COSMESERVICE WILL EXHIBIT AT COSMOPROF BOLOGNA 2023

From 16th to 18th March 2023 COSMESERVICE will be exhibiting at Cosmoprof Bologna, one of the most important beauty trade fairs in the world!

Save the date! We are thrilled to announce that COSMESERVICE will exhibit at Cosmoprof Worldwide Bologna, and we invite you to visit us at HALL 16 , STAND F17A. This is a unique opportunity to discover the features and benefits of our services, and learn more about how we can help you to meet your needs. Our team will be on hand to answer any questions you may have.

Cosmeservice has the knowledge and experience to guide you through the regulatory requirements and compliance issues that must be met in order to export your products to the EU, UK, and USA markets. We can help you with the necessary documentation, testing, and certifications required by the authorities to notify your cosmetic product into the EU CPNP, UK SCPN, and USA FDA in compliance with the current regulations.

Cosmoprof Bologna is a great place to network with other industry professionals, learn about the latest trends and developments in the beauty industry, and gain insights into the latest regulatory changes.

We are looking forward to meeting and connecting with you. Don’t miss the chance to visit us at our booth and discover our latest services, we would be happy to welcome you there!

Contact us at info@cosmeservice.com or visit our website if you have any questions!

51st Amendment to IFRA Standards

IFRA (the International Perfumery Association), is the main self-regulatory association of the fragrance industry. IFRA is preparing the 51st Amendment to its standards, which has been open for consultation from June 30 to November 30 and has been extended until February 28, 2023, in order to give the industry the opportunity to present its observations.

IFRA standards, objective:

The standards are set by consensus, placing homogeneous rules on fragrance ingredients that allow manufacturers to work with safety guarantees. Compliance with IFRA standards is mandatory for all its associates, including companies belonging to IFRA member associations.

51st IFRA Amendment: Official notification expected in June 2023.

The 51st Amendment will introduce 51 New Fragrance Ingredient Standards, listed here:

– 34 restriction standards: skin sensitization and systemic toxicity.
– 11 restriction standards: skin sensitization – QRA2.
– 2 restriction standards: systemic toxicity (TTC).
– 1 new restriction standard: depigmenting potential.
– 1 new standard banned for genotoxicity (limited impact – Aroma).
– 12 existing standards revised.
– New annexes.

There are numerous changes and adaptations that the cosmetics industry must face continuously to adjust to the standards and regulations set in Europe and around the world. From Cosmeservice we want to keep you up to date with all the changes that affect the sector, in order to anticipate and be prepared for the entry into force of new standards and regulations.

Please contact us at info@cosmeservice.com if you need any advice about this subject.

COSMESERVICE NEWSLETTER

Our team would like to remind you about the most significant changes that have taken place in the cosmetic industry in the last few months.

Click here to subscribe to our LinkedIn newsletter to stay up to date on the cosmetic sector.

 

  • New version of the Regulation (EC) 1223/2009 published

The new version of the cosmetic regulation was published on the 17th of December 2022.

Now, it can be found all formats updated and all languages available. Since the las amendment, no ingredients were included, as it was not published any amendment of the annexes of the Regulation (EC) 1223/2009.

You can find the newest version of the document here:

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02009R1223-20221217

 

  • FDA Cosmetics Reform Expected to Become Law Soon

On December 23, 2022, The Congress of the United States passed the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act of 2023. FDORA includes, as subtitle E, the Modernization of Cosmetics Regulation Act of 2022, called MoCRA.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), as it has been titled, will add significant new authorities to chapter VI of the Federal Food, Drug, and Cosmetic Act (“FDCA”)—the first major amendments to FDA’s cosmetics authorities since 1938.

It will include new requirements for cosmetics. MoCRA focuses on safety of cosmetics and, among other things, FDA is to develop and issue good manufacturing practice, industry will become subject to registration and listing requirements, must have records to substantiate safety of its products, and must report serious side effects to FDA.

MoCRA also gives FDA mandatory recall authority and expands FDA’s access to certain records. The requirements for registration and listing and new enforcement provisions become effective one year after enactment of the legislation.

https://www.congress.gov/bill/117th-congress/senate-bill/4348/text#id6fd33600-0f2e-4243-bcd4-c6893e6d0cfd

 

  • The 18th ATP and Omnibus Act VI will apply will apply from December 1, 2023.

The corrigendum to Commission Delegated Regulation (EU) 2022/692 of May 25, 2022, includes the substances recently classified as carcinogenic, mutagenic, or toxic for reproduction (CMR). There are 30 substances that are used as cosmetic ingredients, but not widely used, as the industry was not defending them. Benzophenone or Cumene, among other substances will become prohibited for use in cosmetic products from the 1st December 2022.

If you need help to review your products or if you need the complete list, just contact us!

More info here: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R0692

 

  • Omnibus Act V came into force as of 17 December 2022.

Omnibus V will be fully applicable since 17th December 2022 and the 14 substances listed will be prohibited at cosmetic products. Moreover, Methyl Salicylate will be added to Annex III to the EU Cosmetics Regulation, limiting its use.

Hence, as 17th December 2022, cosmetics cannot be placed on the EU market if they are not compliant with Omnibus Act V, and the existing ones on the market must be recalled.

More info here: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R1531

 

  • UK RP data: the deadline (which was scheduled for January 1, 2023) has been extended to the 1st January 2026.

Cosmetic products marketed in the UK must bear the Responsible Person information, the name and address located in the UK. Name, address and country of origin requirements are satisfied if the labelling is in compliance with Article 19 of the EU Cosmetics Regulation.

Therefore, there is a 5-year grace period, until 31st December 2025 to label cosmetic products under the rules of the Article 19 (1)(a) transitional arrangements UKCR. In September 2022, the original 2-year grace period has been extended to 5 years.

Thus, the products with the EU RP on the labelling can be made available on the UK market until December 2025 and from the 1st of January 2026, the UK Responsible Person data must appear on the labelling of the cosmetic products.

 

  • Draft Community Rolling Action Plan (CoRAP) update for years 2023-2025 published

The draft is for an annual update of the CoRAP and covers the three subsequent years 2023-2025. It contains substances suspected of posing a risk to human health or the environment. Substance evaluation is the process under REACH Regulation (EC) No 1907/2006 (Articles 44 to 48) that allows generation of information for clarification of such potential risks.

The draft CoRAP contains 24 substances, including 6 new substances compared to the current CoRAP 2022-2024; 5 substances are being planned for evaluation in 2023, and 19 are divided for evaluation in 2024 and 2025.

By publishing this draft now, ECHA wishes to inform the stakeholders of the progress made and to facilitate early communication between the involved registrants and the relevant evaluating Member State Competent Authority.

More info here: https://echa.europa.eu/es/regulations/reach/evaluation/substance-evaluation/community-rolling-action-plan

 

If you have any questions, please do not hesitate to write to us, our team will be happy to help you.

Please write an email to info@cosmeservice.com or visit our website at www.cosmeservice.com

COSMESERVICE NEWSLETTER

Our team would like to remind you about the most significant changes that have taken place in the cosmetic industry in the last few months.

Click here to subscribe to our LinkedIn newsletter to stay up to date on the cosmetic sector.

  • Methyl-N-methylanthranilate (M-N-MA), a hidden fragrance ingredient, is now regulated.

Methyl-N-methylanthranilate (CAS No 85-91-6) is a fragrance ingredient, usually not declared at ingredient lists. Until 2022, the use of M-N-MA wasn’t regulated, however, the IFRA 49th Amendment limited its use at 0.1% in several product categories due to its phototoxic effects.

The Commission Regulation (EU) 2022/135 includes in the EU Cosmetics Regulation the conclusions of the SCCS Scientific Advice 1616/20 and the SCCS Opinion 1455/11. According to the new entry in Annex III to the EU Cosmetics Regulation, M-N-MA can be used:

  • In leave-on products up to 0.1%;
  • In rinse-off products up to 0.2%.

Moreover, M-N-MA cannot be used with nitrosating agents, allowing a maximum of nitrosamine content of 50 μg/kg, and products containing M-N-MA must be stored in nitrite-free containers.

Lastly, Methyl-N-methylanthranilate cannot be used in leave-on “sunscreen products and products marketed for exposure to natural or artificial UV light”

Products that do not meet the requirements must be off shelves, as the end date was last 21st November 2022.

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R0135

 

  • Regulation (EC) 1223/2009 new updated version, October 2022, consolidated text.

The new version of the cosmetic regulation was published on the 6th of October 2022. This new version includes the amendments made since the last time updated, 31st July 2022.

At the consolidated text the amendment including the last Omnibus can be found, along with the latest changes about Methyl Salicylate.

The Commission Regulation (EU) 2022/1531 was published in September. The so-called Omnibus V Regulation will enter into force on 17th December 2022, prohibiting different substances for their use in cosmetics and limiting the use of Methyl Salicylate.

Since Methyl Salicylate is a fragrance ingredient and it is not disclosed by fragrance suppliers, we recommend you to ask your fragrance supplier about Methyl Salicylate to ensure compliance of your cosmetic products.

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02009R1223-20221006

 

  • FRANCE –Labelling Requirements for Leave-on Products Containing Phenoxyethanol

In 2019, the French Authorities published a legal requirement related to Phenoxyethanol containing leave-on products, also known as the “ANSM Decision March 13th, 2019”. Product labels of all leave-on cosmetic products intended for the French market were requested to bear the warning “Not to be used on the nappy-skin area of children under 3 years of age”.

This administrative decision led to a dispute between the Federation of Beauty Companies (FEBEA) and the National Agency for the Safety of Medicinal Products and Health Products (ANSM). It escalated finally up to the EU Court of Justice, to clarify the interpretation of Article 27 of Regulation 1223/2009.

The requirement for the labeling of the precautionary measurement “Not to be used on the nappy-skin area of children under 3 years of age” on leave-on cosmetic products containing Phenoxyethanol has been repealed. Therefore, the labeling restriction related to Phenoxyethanol is officially not mandatory for products imported into France.

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A62021CJ0004

 

  • The General Court annuls the Commission Delegated Regulation of 2019 about the harmonised classification and labeling of titanium dioxide as a carcinogenic substance.

Titanium dioxide is an inorganic chemical substance used for its colorant and covering properties in various products. In 2016, a proposal to classify titanium dioxide as a carcinogenic substance was submitted to the European Chemicals Agency (ECHA).

The following year, ECHA’s Committee for Risk Assessment (‘the RAC’) adopted an opinion classifying titanium dioxide as a category 2 carcinogen, and the European Commission adopted Regulation 2020/217, recognizing that that substance was suspected of being carcinogenic to humans by inhalation.

The General Court concludes now, by upholding the conclusion contained in the RAC Opinion that the mode of action of carcinogenicity on which that committee relied could not be regarded as intrinsic toxicity in the classical sense, but which had to be taken into consideration in the context of harmonised classification and labeling under Regulation No 1272/2008, the Commission committed a manifest error of assessment.

https://curia.europa.eu/jcms/upload/docs/application/pdf/2022-11/cp220190en.pdf

 

  • Commission Regulation (EU) 2022/2195 of 10 November 2022 as regards the use of Butylated Hydroxytoluene, Acid Yellow 3, Homosalate, HAA299, and Resorcinol in cosmetic products.

The amendment includes specific limits of use to Butylated Hydroxytoluene (BHT) and Acid Yellow, and limits the use of Homosalate. Also includes a new UV filter at Annex VI.

BHT is permitted in mouthwash products, up to 0.001%; in toothpaste, up to 0.1%; and in other leave-on and rinse-off products, up to 0.8%.

Moreover, the draft Regulation limits the use of Acid Yellow to non-oxidative hair dye products at a maximum concentration of 0.5%. Any other use not explicitly regulated will not be allowed.

After the publication of the amendment, the use of Homosalate is restricted to face products with the exception of propellent spray products, and forbidden at the rest.

The use of the substance Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine in regular and nano form is allowed as a UV filter up to 10%.

Finally, the entrance at annex III for Resorcinol has been modified, changing its use. Since now the substance is allowed at professional level in products intended for coloring eyelashes.

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R2195

 

If you have any questions, please do not hesitate to contact us and our team will be happy to help you.

Please write an email to info@cosmeservice.com or visit our website at www.cosmeservice.com

 

 

 

Methyl-N-methylanthranilate. A hidden fragrance ingredient, now regulated.

  • What is M-N-MA?

Methyl-N-methylanthranilate (CAS No 85-91-6) is a fragrance ingredient, usually not declared on the ingredient list. Until 2022, the use of M-N-MA wasn’t regulated, however, the IFRA 49th Amendment limited its use to 0.1% in several product categories due to its phototoxic effects.

The European Commission mandated the Scientific Committee on Consumer Safety (SCCS) to assess whether its use is safe in cosmetic products due to the ingredient photosensitivity.

  • Which restrictions apply to M-N-MA?

The Commission Regulation (EU) 2022/135 includes in the EU Cosmetics Regulation the conclusions of the SCCS Scientific Advice 1616/20 and the SCCS Opinion 1455/11.

According to the new entry in Annex III to the EU Cosmetics Regulation, M-N-MA can be used:

  • In leave-on products up to 0.1%;
  • In rinse-off products up to 0.2%.

Moreover, M-N-MA cannot be used with nitrosating agents, allowing a maximum of nitrosamine content of 50 μg/kg, and products containing M-N-MA must be stored in nitrite-free containers.

Lastly, Methyl-N-methylanthranilate cannot be used in leave-on “sunscreen products and products marketed for exposure to natural or artificial UV light”

  • Deadline for M-N-MA

The European Commission provided some deadlines to implement the changes and last 21st November 2022, products that do not meet the requirements must be off shelves.

  • References

European Commission (2022). Commission Regulation (EU) 2022/135 of 31 January 2022 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of Methyl-N-methylanthranilate in cosmetic products.
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R0135

European Commission. (2021). Scientific Advice on the SCCS Opinion on Methyl N-methylanthranilate (SCCS/1455/11).
https://ec.europa.eu/health/system/files/2021-11/sccs_o_242.pdf

IFRA Standard. (2020). Amendment 49. Methyl N-methylanthranilate.
https://ifrafragrance.org/standards/IFRA_STD_094.pdf

 

We recommend you to ask your fragrance supplier about the presence of Methyl-N-methylanthranilate (M-N-MA) in your fragrances.

If you have further questions do not hesitate to contact us at info@cosmeservice.com, we will be glad to help!

 

COSMESERVICE TEAM
www.cosmeservice.com

COSMESERVICE NEWSLETTER 

Our team would like to remind you about the most significant changes that have taken place in the cosmetic industry in the last few months.

Click here to subscribe to our LinkedIn newsletter to stay up to date on the cosmetic sector.

Lowered the allowed level of homosalate

The UV filter Homosalate was included in the list of potential endocrine disruptors to be evaluated. In June 2021, the SCCS released its Final Opinion 1622/20, stating that the present limit for Homosalate as a UV filter (10% in the finished product) is not safe.

Following the SCCS Scientific Advice 1638/21 of December 2021, the European Commission published a draft of Annex VI of the Regulation (EC) 1223/2009, restricting the use of Homosalate.

According to the draft Regulation, it can only be used in face products except for propellant sprays, up to a maximum concentration of 7.34%.

So, this means that Homosalate can be used in face creams applied as creams, but not for propellant sprayed solutions.

The application deadlines are as follows:

  • 24 months after the entry into force of the draft Regulation for placing on the market;
  • 30 months after the entry into force for making available.

Microplastics – Draft of the new EU rules published.

Microplastics are intentionally added to a range of products including fertilisers, plant protection products, cosmetics, household and industrial detergents, cleaning products, paints and products used in the oil and gas industry.

In 2017, the European Commission requested ECHA to assess the scientific evidence for taking regulatory action at the EU level on microplastics, and the Commission has prepared its draft. This was published on the 30th of August 2022 and was discussed for the first time with the Member States in the REACH Committee on 23 September 2022.

Annex XVII of REACH Regulation will be amended restricting synthetic polymer microparticles, polymers that are solid and which either are contained in particles, fulfilling different conditions listed.

Also is excluding different polymers that are the result of a polymerisation process that has taken place in nature, degradable polymers, polymers with solubility greater than 2 g/L, and polymers that do not contain carbon atoms in their chemical structure, and an appendix of the amendment will lay down the rules for proving degradability of polymers, publishing different methods to ensure the compliance with the different restrictions.

You can read our full article at our website: Cosmeservice.com-microplastics-draft

For further details, see the complete draft regulation at: https://ec.europa.eu/transparency/comitology-register/screen/documents/083921/1/consult?lang=en

Final opinion on Genistein and Daidzein

On the 23rd of September 2022, the Scientific Committee on Consumer Safety (SCCS) published its Final Opinion on Genistein and Daidzein. A corrigendum, to correct the bioavailability oral route for daidzein was adopted on the 11th of October 2022.

From the safety assessment based on the available relevant data on the aglycone form of genistein and daidzein, and in consideration of the potential endocrine disrupting properties of phytoestrogens, the SCCS considers that:

  1. a) the use of Genistein in cosmetic products up to a maximum concentration of 0.007% is safe.
  2. b) the use of Daidzein in cosmetic products up to a maximum concentration of 0.02% is safe.

For more information, see the complete Opinion at: https://health.ec.europa.eu/system/files/2022-10/sccs_o_263.pdf 

Omnibus Act VI will be effective from the 1st of December 2023

On the 3rd of May 2022, the European Commission published the Commission Delegated Regulation (EU) 2022/692, also known as the 18th Adaptation to Technical Progress (ATP). The law includes the substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR). Among them, there are new 30 substances that are also used as cosmetic ingredients, which will become prohibited for use in cosmetic products.

According to the Omnibus Act VI draft, substances such as Benzophenone, Cumene or Ammonium bromide will be prohibited in cosmetic products.

If you have any questions, please do not hesitate to contact us and our team will be happy to help you.

Please write an email to info@cosmeservice.com or visit our website at www.cosmeservice.com

COSMESERVICE TEAM

 

MICROPLASTICS – DRAFT OF THE NEW EU RULES PUBLISHED

Plastics make our lives easier in many ways and are often lighter or cost less than alternative materials. Although plastic is an important material in our everyday life, this type of waste is increasing rapidly.

If the plastic is not properly disposed of or recycled, it may end up in the environment where they stay for centuries and degrade into smaller and smaller pieces. These small pieces (typically smaller than 5mm) are called microplastics and they are of concern.

Microplastics are intentionally added to a range of products including fertilizers, plant protection products, cosmetics, household, and industrial detergents, cleaning products, paints, and products used in the oil and gas industry.

As the EU vision highlights moving towards a more sustainable plastics economy, all players in the supply chain need to play a role.

In 2017, the European Commission requested ECHA to assess the scientific evidence for taking regulatory action at the EU level on microplastics that are intentionally added to products, and in January 2019, ECHA proposed a wide-ranging restriction on microplastics in products placed on the EU/EEA market to avoid or reduce their release to the environment.

ECHA’s Committee for Risk Assessment (RAC) adopted its opinion in June 2020 and the Committee for Socio-economic Analysis (SEAC) adopted its opinion in December 2020.

The Commission has prepared its draft regulation following ECHA’s report and the committees’ combined opinion. This was published on in 30th August 2022 and was discussed for the first time with the Member States in the REACH Committee on 23 September 2022.

Annex XVII of REACH Regulation will be amended restricting synthetic polymer microparticles, polymers that are solid and which either are contained in particles and constitute at least 1 % by weight of those particles, or build a continuous surface coating on particles, where at least 1 % by weight of those particles fulfilling different conditions listed.

Also excludes different polymers that are the result of a polymerization process that has taken place in nature, which are not chemically modified substances; degradable polymers, polymers with solubility greater than 2 g/L, and polymers that do not contain carbon atoms in their chemical structure.

An appendix of the amendment lays down the rules for proving the degradability of polymers, publishing different methods to ensure compliance with the different restrictions, and shall be conducted by laboratories complying with the principles of good laboratory practice provided for in Directive 2004/10/EC or other international standards recognized as being equivalent by the Commission or the Agency or accredited to ISO 17025.

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

For more information and details, see the complete draft regulation at: https://ec.europa.eu/transparency/comitology-register/screen/documents/083921/1/consult?lang=en

COSMESERVICE WILL ATTEND COSMOPROF ASIA 2022

We are very excited to announce that COSMESERVICE will attend COSMOPROF ASIA (Singapore special edition), our last on-site fair of the year.

Save the date!! Cosmeservice is getting ready one more time at the stunning fair COSMOPROF ASIA! Taking place from November 16th to 18th. We will be waiting for you at HALL Nº 3, STAND Nº 3-J10. Meet our cosmetic regulatory experts and start selling your cosmetic products worldwide with the help of COSMESERVICE.

An opportunity like this would be a great way to discuss recent cosmetic industry regulatory changes.

You can check all the information at  https://www.cosmoprof-asia.com/

We like to listen, observe and learn. Tell us your concerns, we create value relationships and continuous improvement towards excellence. See you soon in Cosmoprof Asia 2022!

Please, contact us directly if you want to arrange a meeting: info@cosmeservice.com 

METHYL SALICYLATE – Limits of use modified

Methyl Salicylate (CAS no. 119-36-8) is a substance with different functions in cosmetics formulas, it can be used as fragrance/flavoring ingredient and soothing agent.

In May 2021, ECHA classified Methyl Salicylate as a CMR substance of category 2: suspected to be toxic for reproduction. As the ingredient is widely used, the cosmetic industry asked the European Commission to apply the exemption procedure set by Article 15(1) of the EU Cosmetics Regulation. According to it, the use of a substance classified as CMR 2 can be permitted by way of exemption if the Scientific Committee on Consumer Safety (SCCS) evaluates the substance and finds that is safe.

As a result, on October 26-27, 2021, the SCCS issued its final opinion on Methyl Salicylate (SCCS/1633/21), stating the maximum safe concentration of the ingredient for several categories of cosmetics.

Following this SCCS opinion and analysis, the European Commission published the Omnibus Act V 15th September 2022. The new restrictions will apply as of December 17, 2022 — the exact date from which the 17th ATP will be applicable.

Restrictions of use:

  • Up to 0.06% in leave-on skin products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant, and hydroalcoholic-based fragrances) and leave-on hair products (except spray/aerosol products);
  • Up to 0.05% in face makeup (except lip products, eye makeup, and makeup remover);
  • Up to 0.002% in eye makeup and makeup remover;
  • Up to 0.009% in leave-on hair products spray/aerosol;
  • Up to 0.003% in deodorant spray/aerosol;
  • Up to 0.4% in body lotion spray/aerosol;
  • Up to 0.06% in rinse-off skin products (except hand wash) and rinse-off hair products;
  • Up to 0.6% in hand wash, hydroalcoholic-based fragrances, and mouthwash intended for children above 10 years of age and adults;
  • Up to 0.03% in lip products;
  • Up to 2.52% in toothpaste;
  • Up to 0.1% in mouthwash intended for children aged 6-10 years;
  • Up to 0.65% in mouth spray.

Furthermore, cosmetic products for children under six years cannot contain Methyl Salicylate, with the exception of toothpaste.

Deadline

Please, take into account that Omnibus Acts do not differentiate between placing on the market and making available on the market of the substances listed. Hence, as of 17th December 2022, cosmetic products cannot be placed on the market nor also being available on the shelves if they are not compliant with Omnibus Act V.

Please contact us if you need any advice about your products. 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.

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R1531

 

COSMESERVICE TEAM

New draft published by the European Commission. More than 80 allergens to be declared.

New draft published by the European Commission with more than 80 substances

Yesterday, 15th September 2022, the European Commission notified the WTO of a new amendment to the Cosmetic Regulation. The publication is amending Regulation (EC) No 1223/2009 of the European Parliament and the Council as regards labelling of fragrance allergens in cosmetic products.

The draft measure proposes additional fragrance allergens must be individually labelled on the package of a cosmetic product if their concentration exceeds 0,001 % in leave-on products and 0,01 % in rinse-off products. It further introduces some updates and simplifications in the names of those substances. It will be all done through amendments of Annex III to Regulation (EC) No 1223/2009.

 

What are these substances?

Fragrance substances are organic compounds with characteristic, usually pleasant, odours. They are widely used in perfumes and other perfumed cosmetic products, but also in many other products such as detergents, fabric softeners and other household products.

These substances are linked to contact allergy, which is a life-long, altered specific reactivity in the human immune system. Different measures aim to protect the whole population from acquiring fragrance allergies (primary prevention) and to protect sensitised individuals from developing allergy symptoms (secondary prevention).

 

Which risk do they have? What we can do to minimise it?

In accordance with Cosmetics Regulation (EC) No 1223/2009, a cosmetic product is to be made available on the Union market only where a list of ingredients is indicated on its packaging. Furthermore, it is specified that perfume and aromatic compositions and their raw material are to be referred to by the terms ‘parfum’ or ‘aroma’ in the list of ingredients and complemented by substances the mention of which is required under the column ‘Other’ in Annex III to that Regulation.

Currently, 25 fragrance allergens listed in entries 67 to 92 of Annex III to Regulation (EC) No 1223/2009 are to be mentioned in the list of ingredients (individually labelled), along with the INCI name of the fragrance, “parfum” grouping the rest of substances the fragrance has.

In response to the request of the Commission for an update of the list of individually labelled fragrance allergens, the Scientific Committee on Consumer Safety (SCCS) adopted an opinion at its plenary meeting on 26-27 June 2012, confirming the fragrance allergens listed on Annex III to Regulation (EC) No 1223/2009 are still relevant, but the SCCS identified 56 additional fragrance allergens, which have clearly caused allergies in humans and which have currently no requirement of individual labelling.

 

Measures adopted by the European Commission

With the aim to protect the safety of the European consumers, an obligation to individually label those new fragrance allergens will be introduced in Annex III to Regulation (EC) No 1223/2009, when their concentration exceeds 0,001 % in leave-on products and 0,01 % in rinse-off products.

For reasons of consistency and clarity, also for completeness, certain existing entries for fragrance allergens will be updated, by aligning common names of the substances to those of the latest version of the Common Ingredients Glossary referred to in Article 33 of that Regulation, and by grouping similar substances in one entry. It is also necessary to update certain existing entries for fragrance allergens by adding isomers and by complementing and amending the respective CAS and EC numbers.

 

What has to be done now?

As the updated list of fragrance allergens is likely to result in entries in Annex III to Regulation (EC) 1223/2009 combining existing and new restrictions, economic operators should be allowed a reasonable period of time to adapt to them by making the adjustments to product formulations and containers that are necessary to ensure that only cosmetic products complying with the new requirements are placed on the market.

This gives the cosmetic companies and fragrance manufacturers a period of 3 years after the date of entry into force of this Regulation to place cosmetic products containing those substances and not complying with the restrictions on the Union market. Also, the companies and manufacturers should also be allowed a reasonable period of time to withdraw from the market cosmetic products which do not comply with the new requirements, a period of 5 years after the date of entry into force of this Regulation will be allowed.

The list of substances to be declared as allergens will grow to more than 80 individual substances, and the INCI names will be placed on the ingredient list of the cosmetic products when their concentration exceeds 0,001 % in leave-on products and 0,01 % in rinse-off products.

This draft lists 56 new entries that will be added and amended in Annex III of Regulation 1223/2009, and from now on, these substances and their derivatives must be taken into account.

If you need an exhaustive list of the substances, do not hesitate to contact us, we will be glad to help.

 

Brief summary. Dates and actions to take.

The draft of the amendment published will be open to comments 60 days from the notification and, when all comments will be revised, the European Commission will publish the amendment, presumably in the first half of 2023.

This period of time will enable the cosmetic companies and fragrance manufacturers to update the documents of the cosmetic products, along with the labelling of cosmetic products. A new allergen certificate will be needed, listing all the substances included in the amendment and their concentrations, to be able to calculate if the substances need to be declared on the ingredient list of the different cosmetic products.

The expected dates and periods are:

  • The draft is open to comments during the next 60 days.
  • The European Commission will publish the amendment first quarter of 2023.
  • The amendment will come into force 20 days after its publication in the Official Journey of the European Commission.
  • 3-year period to be able to place into the EU market cosmetic products not in compliance with the published regulation. This will allow companies to revise the documents and labels of their products.
  • 5-year period to remove from the shelves of the EU market cosmetic products not in compliance with the published regulation. This will allow companies to get rid of the stock and place revised products.

Please contact us if you need any advice about your products. 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 https://www.cosmeservice.com.

 

Useful links:

https://members.wto.org/crnattachments/2022/TBT/EEC/22_6171_01_e.pdf

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02009R1223-20220731&from=EN

 

COSMESERVICE TEAM