Cosmetics & Personal Care | Monthly bulletin | October 2019
Regulatory news - Eurofins updates - Commercial news
Upcoming dates of application: Annex II - Cosmetic Regulation and Annex XVII - REACH
As a reminder, following you will a summary of the legislation that will start applying within the next six months:
Manufacturers and importers should carefully consider these coming dates of application and confirm that their products comply with these restrictions:
- Commission Regulation (EU) 2017/1410 of 2 August 2017 amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products.
From 23th August 2019 cosmetic products containing one or more of the following substances shall not be placed on the Union market.
From 23th August 2021 cosmetic products containing one or more of the following substances shall not be made available on the Union market.
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Reference number |
Substance identification |
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Chemical name/INN |
CAS number |
EC number |
|
|
1380 |
3- and 4-(4-Hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC) |
51414-25-6/ 31906-04-4/ |
257-187-9/ 250-863-4/ |
|
1381 |
2,6-Dihydroxy-4-methyl-benzaldehyde (atranol) |
526-37-4 |
— |
|
1382 |
3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde (chloroatranol) |
57074-21-2 |
— |
- Commission Regulation (EU) 2018/35 of 10 January 2018 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards octamethylcyclotetrasiloxane (‘D4’) and decamethylcyclopentasiloxane (‘D5’).
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In Annex XVII to Regulation (EC) No 1907/2006, the following new entry is added: |
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Entry 70 |
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Octamethylcyclotetrasiloxane (D4) CAS No 556-67-2 EC No 209-136-7 Decamethylcyclopentasiloxane (D5) CAS No 541-02-6 EC No 208-764-9 |
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It will start applying on 31st January 2020.
Recent publications by European Commission
Below you will find some documents recently published in the Official Journal of the European Union related to Cosmetic products:
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Date |
Reference |
Title |
|
22-8-2019 |
Decision of the EEA Joint Committee No 196/2017 of 27 October 2017 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2019/1359] |
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26-06-2019 |
Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (Text with EEA relevance)Text with EEA relevance |
Recent SCCS publications on Cosmetics
Following some recent publications of Scientific Committee on Consumer Safety (SCCS):
Preliminary opinion on cosmetic ingredients:
Final Opinion:
- SCCS - Final Opinion on Allergy Alert Test (AAT) as a proof-of-concept study
- SCCS - Final opinion on the safety of fragrance ingredient Acetylated Vetiver Oil (AVO) - (Vetiveria zizanioides root extract acetylated) - Submission III
Some cosmetic and aesthetic products become Medical device
On 26th May 2020, the new regulations for medical devices will be fully applicable. At first we could think that it does not affect cosmetic products, but this is not the case. According to Annex XVI of the Medical Device Regulation (EU) 2017/745, the following cosmetic and aesthetic products have been redefined as medical devices:
- Colored contact lenses
- Liposuction equipment
- Collagen implants
- Tattoo removal equipment
- Dermal fillers
- Laser or Intense Pulsed Light (IPL) hair removal equipment
- Skin resurfacing equipment
Affected manufactures, importers and distributors will have to meet CE mark certification requirements and maintain certification. The main points of medical device regulation compliance are:
- CE Mark
- CE certification
- Classifying their products according to the regulation
- Partnering with a designated Notified Body
- Implementing a quality management system (EN ISO 13485:2016)
- Companies with no physical presence in the EU will need to appoint a European Authorized Representative for in-country representation
- Risk management plan
- Post-market surveillance requirements
- Clinical evaluation reporting
Same chemical safety standards of the European Union
In January 2019, the State of Connecticut published the proposal Bill Nº 75:
Act requiring cosmetics sold and manufactured in connecticut to meet chemical safety standards of the European union.
This proposal comes from the fact that hundreds of potentially harmful ingredients (banned in the EU) are legally allowed in the US.
Many American consumers are unaware that they are absorbing untested and unsafe chemicals though their cosmetic products.
Below you will find a monthly summary of product recalls and alerts in Europe (Source “RAPEX”) and in the US (Source “CPSC”).
Europe
RAPEX (European Commission Rapid Alert System for dangerous non-food products – Alerts reported by EU national authorities).
The following 6 alerts regarding Cosmetic & Personal Care products. have been reported, from week 34 until week 38 of 2019.
|
Type of Risk |
Number of alerts |
Notes |
|
Chemical
|
5 |
Glue for false nails contains chloroform (measured concentration 26.8% in weight) |
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Eyelash growth serum contains the active substance bimatoprost |
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Cosmetic gel contains a mixture of the preservatives methylchloroisothiazolinone and methylisothiazolinone (MCI/MI), which is not permitted in leave-on cosmetic products |
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Microbiological |
1 |
Hair colouring product: The product contains an excessive amount of aerobic mesophilic bacteria (measured values exceeding 100 cfu/g) |
From on 21st August to 20th September 2019, CPSC (Consumer Product Safety Commission) has published the following recalls: 3 recalls regarding Cosmetic & Personal Care products.
|
Type of Risk |
Number of recalls |
Notes |
|
Poisoning |
3 |
Essential oils: The bottles are not child resistant as required by the Poison Prevention Packaging Act, posing a risk of poisoning to young children if they ingest it |
Are your products Eco-friendly?
The consumers are more and more aware about the environmental impact of the products they use. The cosmetic industry is highly concerned by these new challenges. This was the topic of the JEST organized by COSMED on October, 27th. Eurofins presented how to evaluate the biodegradability of raw materials, finished products and packaging.
Eurofins offers a complete range of testing to assess the biodegradability of your products:
- Raw materials are tested according to REACH requirements and OECD guidelines
- Finished products are analyzed using OECD guidelines and our expertise
- Packaging are evaluated according to ISO standards
In addition, our expert laboratories can evaluate the Ecotoxicity of your products according to standards or tailor-made protocols. For example, suncare product can be tested on sea algae, corals, etc.
Meet us at Congrès Parfums & Cosmétique in Chartres
On the occasion of the congress which will be held from the 6th - 7th of November, Eurofins Cosmetics & Personal Care will be sponsor and present our unique offer on safety: regulatory & toxicology, determination of impurities, in vitro safety and clinical safety.
Meet us at Cosmopack Asia
Eurofins Cosmetics & Personal Care will be pleased to welcome you on booth 10-P06 of the Cosmopack Asia, at the AsiaWorld Expo, on November 12th,13th and 14th. Our team will introduce its latest innovations and novel testing for the Cosmetic and Personal Care market.
Meet us at Making Cosmetics
Our speech will be held by Marco on microbiome on November, 21st at 12:10. Skin microbiome science is at his rising point. An integrated approach including dermatological and instrumental validation is mandatory to acquire reliable data. Eurofins Cosmetics & Personal Care is developing customized protocol to benefit at best from metagenomics NGS technologies.
SCS Formulate Creating Cosmetics
Eurofins Cosmetics & Personal Care UK will be attending the annual SCS Formulate Creating Cosmetics event in November in Coventry. The UK service is a one stop solution provider for UK formulators and manufacturers. New techniques will be showcased at the event supporting Microbiome, Blue Light and Anti-Pollution studies. More information on the event can be found at SCS Formulate. Contact: Samantha Booth
