In the case of borderline cosmetics-toys products, both the Cosmetics Regulation and the Toys Directive aim to ensure that the products are safe for the consumer – but how should they be applied when it comes to assuring the compliance of your products? Read more
Borderline Cosmetics – Toys Products: How to Comply?
France’s new adverse reporting portal for cosmetics
In August 2016, the French Decree No.2016-1151 endorsed the creation of a web based portal for reporting adverse health related events; accessible to healthcare professionals, healthcare authorities as well as the general public. Read more
Certain Eyelash Dyes to be allowed in Cosmetics for Professional Use
Cosmetic claims and labelling under scrutiny
Catalogue of nanomaterials finally published!
Cosmetic Preservatives – What Changed ?
Recently many preservatives have been banned or restricted in cosmetic products. One of the most widely used was the mixture Methylchloroisothiazolinone / Methylisothiazolinone (MCI / MI). This mixture was allowed for use in all cosmetic products up to 0,0015% (3:1). This is no longer the case. Read more
ECHA Launches Public Database of Chemical Substances
17th of March 2017, the European Chemicals Agency (ECHA) launched a publicly accessible database with information on over 15 000 chemical substances. This database is aimed at researchers, regulatory authorities and businesses. Read more
Cosmetic Product Classification
In order to ensure a product is indeed a cosmetic product, the product formulation, characteristics, sites of application and intended functions must match the definition of a cosmetic product as defined in the scope of Cosmetic Regulation EC 1223/2009, which came into effect in 2013.
Once the product has been found to match the definition of a cosmetic product (as per Art. 2 p.1a) the cosmetic product categories listed in regulation EC/1223/2009 (in preamble 7) need to be considered. The next step is then to outline how products can be grouped together as product families, thus determining the creation of the respective PIF.
EU Commission restricts the use of hair dyes and Benzophenone-3
EU Commission restricts the use of hair dyes and Benzophenone-3
Last week, the EU Commission announced two amendments to the current Cosmetic Regulation (EC) No 1223/2009. Published amendments to Annex III and Annex VI of the Regulation restrict the use of hair and eyelash dye substances, as well as Benzophenone-3.
Amendment of Annex III regarding hair and eyelash dyes
In 2001, the Scientific Committee on Cosmetic Products and Non-Food Products (SCCP) conducted a study on the use of permanent hair dyes and the risk of bladder cancer. The study discovered a potential risk in the use of hair and eyelash dyes. As a result, the EU Commission has issued an amendment to the Cosmetic Regulation, restricting the use of such substances. The amendment lists all the updated requirements, including additional mandatory testing for genotoxicity and carcinogenicity.
Obelis “Success Story” in the Belgian Cosmetics Catalogue!
Obelis has been listed in the official Belgian Cosmetics Catalogue 2016! The catalogue, published in September 2016 by the Belgian Federal Agency for Exportations, presents the most up-to-date insight into the Belgian cosmetics industry (its size, turnover, export rate) as well as lists of all the key players and stakeholders. Obelis, being one of them, received a special mention in the ‘Belgian Success Stories’ section, where an interview with Obelis CCO (Mrs. Sandra Ferretti) has been published. Read more
3 Leading Factors That Can Expedite Sales to Europe
Obelis to organize the First International Congress on Cosmetics Regulations!
Obelis, together with BioEvents, is organizing the first edition of International Congress on European Regulations and Compliance for Cosmetic (CRCC 2016). The congress will take place between 7th and 8th November, at the Hilton Prague, in Prague, Czech Republic. It will bring together cosmetics industry professionals from all over the world, interested in learning more about the EU compliance process for beauty products.
Revision of SCCS Guidance on the Safety of Cosmetics – What has Changed?
Notes of guidance:
The latest edition of the “Notes of guidance for testing of Cosmetic Ingredients and their Safety Assessment” has been issued and closed for comments following the deadline of 8th of January 2016. This is a document issued periodically by the SCCS, with the purpose of improving the compliance of cosmetic products with the last amended cosmetics regulation (1223/2009/EC). The previous edition was issued in 2012, having seen since then several amendments, and new opinions have been published thereafter. All these modifications form the basis of a new revision. Read more
Fragrance Industry – The End of Animal Testing in Allergen Risk Assessment
On the 16th of December 2015, during the third annual review of the IDEA Project regarding risk assessment methodologies processes and criteria to identify fragrance allergens of concern, the Fragrance Industry reaffirmed its commitment to finding suitable alternatives to animal testing to assess the potency of skin sensitizers. Read more
NEW SCCS opinion on o-Phenylphenol
On December 15th, 2015, the Scientific Committee on Consumer Safety (SCCS) revised its opinion from June 25th on o-Phenylphenol, concluding that lowering the maximum concentration limit for this substance in leave-on cosmetics products is recommendable. Read more
EC identified essential principles in REACH data-sharing
CoRAP 2016-2018 Published
On October 28th, 2015, the European Chemical Agency (ECHA) has published its proposal to update the Community Rolling Action Plan (CoRAP) for 2016-2018. The final plan will be adopted in March next year, and it is expected that the Member States will evaluate 138 substances, 53 of which are newly selected. Read more
ISO 16128 – The future of natural and organic cosmetics
For the past five years, the International Organization for Standardization (ISO) has been discussing harmonized criteria and definitions for natural and organic cosmetics. On the 11th November, the first part of the ISO 16128 – which defines the technical definitions and criteria for natural and organic cosmetic ingredients and products – was finally approved for publishing. Read more
Formaldehyde in Cosmetics – What You Should Know
Formaldehyde has been recommended to be classified as a mutagen of category 2 (may induce heritable mutations) and a category 1B carcinogen (presumed human carcinogen) by the European Chemical Agency (ECHA), since December 2012. This reclassification is to be adopted from the 1st of January 2016 and is expected to have an impact on the nail hardening cosmetics industry, since this reclassification implies that formaldehyde is to be banned from cosmetic products, as per the 1223/2009/EC regulation. Read more
Nano-Hydroxyapatite – is it safe?
On October 16th, 2015, the SCCS published an Opinion on the safety of Hydroxyapatite in its nano form. The opinion will be open for comments until January 8th, 2016. Read more
ZINC OXIDE: Approved as a UV Filter in Cosmetics by the European Commission
NEW EC Request on the safety of Titanium Dioxide (nano) in sunscreens and personal care sprays
On 14th September 2015, the European Commission requested a scientific opinion on the safety of the nano form of Titanium Dioxide (TiO2) when used as UV-Filter in sunscreens and personal care spray products. Read more
The Court of Justice Rules: Contact Lenses Do Not Fall Under the Cosmetics Regulation
On the 3rd of September 2015, the European Court of Justice, delivering the case C-321/14, ruled that corrective color contact lenses do not fall within the scope of the Regulation (EC) No 1223/2009 on cosmetic products. This is despite the outer packaging possibly stating the following: “cosmetic eye accessory, subject to the EU Cosmetics Directive.” Read more
Hair Dyes – NEW SCCS Opinions
On June 25, 2015, the SCCS published updates on the hair dyes: 2,6-Dihydroxyethylamino toluene, 2,5,6-Triamino-4-pyridimidinol sulphate and the new hair dye HC Yellow n.º 17 safety, covering the following points:
SCCS OPINION ON 2,5,6-Triamino-4-pyrimidinol sulfate (Colipa No. A143) and HC Yellow No. 17 (B121). Deadline for comments: 28 October 2015
EC Proposes to Restrict the use of Methylisothiazolinone (MI): Public Consultation now Open.
From the 29th of July 2015 to the 23rd of October 2015 public consultation on the restriction of the use of the preservative Methylisothiazolinone (MI) in cosmetics products is open. The EC proposes to ban MI in leave-on products and to wait for the final SCCS opinion on rinse-off and hair leave-on products, expected at the end of September 2015, before reducing the concentration from 100ppm to 15ppm in other products. Read more
EC Restrict Hair Dye Ingredients after Adoption of New Regulation (EU) 2015/1190
On July 20, 2015 the European Commission adopted Regulation (EU) 2015/1190 thereby amending the Annex III to Regulation (EC) No 1223/2009. The new Regulation, binding in its entirety and directly applicable to all Member States, restricts the use of hair dye substances and was put forward by the Scientific Committee on Consumer Safety.
The Annex III to the Cosmetics Regulation contains a list of cosmetic ingredients that are only allowed in Europe if they comply with the restrictions imposed by the Annex. The new restrictions are the result of further efforts by the European Commission to control the potential health risks of hair dye ingredients in beauty products. Read more
SCCS to pronounce on the safety of four cosmetic ingredients
During the last week of June 2015, the Scientific Committee on Consumer’s Safety (SCCS) were requested to pronounce on the safety of four different cosmetics ingredients of potential concern, as used in various cosmetics formulations: Read more
SCCS Opinion on “Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form)”
Silica, Hydrated Silica, and Silica Surface Modified with Alkyl Silylates (nano form)
Silica, Hydrated Silica, Silica Silylate and Silica Dimethyl Silylate nano forms are used in many leave-on and rinse-off cosmetic products, including skin, hair and nail products. However, these ingredients are not regulated in the Cosmetic Regulation (EC) No 1223/2009, although they are reported in the CosIng Database with several cosmetics functions. Read more
SCCS finally pronounces on α-Arbutin
On the 27th May 2015, the Scientific Committee on Consumers Safety (SCCS) adopted the opinion SCCS/1552/15 on the safety of α-Arbutin, which is currently open for public comments until 22nd July 2015. This long-awaited opinion finally provides a clear conclusion on the safety of this cosmetic ingredient.
This is great news for the skincare sector and the beauty industry, which will see their concerns on this widely used skin-whitening cosmetic ingredient finally clarified. Read more
Opinion on Fragrance Ingredients Tagetes Minuta and T. Patula Extracts and Essential Oils (photo-toxicity)
Photo-toxicity concerns over the extracts and oils from Tagetes spp.
The International Fragrance Association (IFRA) recommends the use of extracts and oils of Tagetes species is limited to up to 0.01% for the following situations:
“For applications on areas of skin exposed to sunshine – excluding bath preparations, soaps and other products which are washed off the skin – oils and absolutes obtained from Tagetes minuta L., syn. Tagetes glandulifera Schrank and Tagetes patula L. should not be used such that the level in the consumer product exceeds 0.01%.” Read more
The TTIP will not get banned ingredients into the EU
In March 2015, the European Commission changed its position concerning cosmetics in the Transatlantic Trade and Investment Partnership (TTIP). This represents a major shift on the impact that the TTIP will have on the EU cosmetics market.
The ecological criteria for the award of the EU Ecolabel for rinse-off cosmetic products
In December 2014 the European Commission published a long-awaited decision on the criteria required to award the Ecolabel for rinse-off cosmetics products. This document set down the basis and European standards to ensure that the same criteria are respected throughout the 29 Member States regarding the so-called ecologic cosmetics.
Cetylpyridinium Chloride – the next cosmetics preservative?
What is Cetylpyridinium Chloride?
Cetylpyridinium Chloride is a well-known raw material with great potential in the prevention of microbial spoilage of various types of products including cosmetics. Despite these characteristics, Cetylpyridinium Chloride is currently not allowed for use as a preservative in EU cosmetic products, as it is not included in the Annex V – Allowed preservatives to be used in cosmetic products of the 1223/2009/EC Cosmetics Regulation
Sun Protection Factor Determination Guidelines
What are sun protection products?
Sun protection products are classified as cosmetics in Europe. Their function is to protect the user from the UVB sun rays that can cause sunburn and may lead to skin cancer.
SCCS to clarify concerns on Arbutin, a skin-whitening cosmetics ingredient
On 25th March 2015, the European Commission requested that the SCCS (Scientific Committee of Consumers Safety) elaborate on their verdicts on α-Arbutin, β-Arbutin and Deoxyarbutin, three chemical forms of Arbutin.
The request follows widespread concern over the safety of this ingredient, extensively discussed in the beauty industry and the EU cosmetics regulatory sector.
Verdict on Dichloromethane open for comments until May 22nd
On the 25th of March 2015 at its 9th plenary meeting the SCCS adopted an opinion on dichloromethane due to recent concerns on its safety.
New NANO UV-Filter Allowed
The European Commission’s Scientific Committee on Consumer Safety (SCCS) has published its verdict on the use of MBBT [2,2’-methylene-bis-(6(2H-benzotriazol-2-yl)-4- (1,1,3,3-tetramethylbutyl)phenol)] and concluded that the substance, used in its nano form as a UV-filter and at a concentration up to 10% in dermally applied cosmetic products, does not pose a risk of adverse effects in humans after application on healthy, intact skin. Read more
EC Issues Comprehensive Paper on Nanomaterials
The European Commission, together with the University of West England (UWE), Bristol, published, in February, a new Thematic Issue called “Nanomaterials functionality”. In this paper, recent developments on nanomaterials applications are presented and the safety for humans and the environment is discussed. Read more
Obelis Blog: Rapex
Fragrance ingredient found unsafe by SCCS
Fragrance ingredient found unsafe by SCCS
In a meeting on 16 December 2014, the SCCS (Scientific Committee of Consumer Safety) adopted the SCCS/1541/14 opinion on the safety of the presence of vetiveryl acetate in leave-on and rinse-off type cosmetic products.
The opinion states that the available data is insufficient to properly assess the safety of the substance. However, there is evidence that vetiveryl acetate is a moderate skin sensitizer; additionally, genotoxic/mutagenic effects have been observed in an Ames test of vetiveryl acetate.
Therefore, the substance is not safe for use in cosmetics at the concentration limits proposed by the IFRA.
Consequently, the Committee has called for further information on the composition of the test substances used in the submitted toxicological studies. Read more
Calls for data on the potential toxicity of Styrene/Acrylates Copolymer, Sodium Styrene/Acroylates Copolymer and Colloidal Silver nanoparticles used in cosmetics products
The consultation period for submitting relevant data on the use of “Styrene/ Acrylates Copolymer (Nano)”, “Sodium Styrene/ Acroylates Copolymer (Nano)” and “Colloidal Silver (Nano)” in cosmetics products to the European Commission is between the 25th of March 2015 and 30th of June 2015.
Member State Authorities, manufacturers of beauty products, producers of the substances concerned, and relevant cosmetics industry and consumers associations are invited to provide their feedback. Read more
Results of the Meeting of the Scientific Committee on Consumer Safety (SCCS) in March
CPNP release 1.5 successfully deployed
On 22 December DG SANCO (Health and Consumers) announced the launch of improved features in the Cosmetic Products Notification Portal. The new functionalities include but are not limited to a transfer of products between Responsible Persons and a more efficient mechanism to download data for Poison Centres and Competent Authorities.
No need to be concerned about BPA, EFSA Confirms
The European Food Safety Agency (EFSA) published in January 2015 a re-evaluation of BPA (bisphenol A) – an additive used in cosmetics packaging, which is totally banned in cosmetic products according to the EU cosmetics regulation. EFSA concludes that the substance poses no health risk to consumers of any age group (including unborn children, infants and adolescents) at current exposure levels.
NEW Opinions Upcoming After the Last Meeting of the Scientific Committee on Consumer Safety (SCCS)
On the 20th of January 2015 took place in Luxembourg the last meeting of the Scientific Committee on Consumer Safety (SCCS). New opinions have been drafted by the Working Group on Cosmetics Ingredients undertaking tasks directly linked to the question submitted by the Commission.
D4 and D5 Silicones UK’s Proposal Of Restrictions
The UK Competent Authorities has expressed the intention to ask the European Chemicals Agency (ECHA) to limit the use of the two cyclosiloxanes D4 (Cyclotetrasiloxane) and D5 (Cyclopentasiloxane). Expected for January 2015, the first deadline for the UK Competent Authorities to submit the restriction proposal to ECHA has been extended until 17 April 2015.
Cosmetics animal testing ban conflict with REACH is solved
The conditions of the animal testing ban in the EU were finally clarified last 27th October 2014, in a communication concerning this conflictive contact point between the REACH Regulation 1907/2006 and the EU Cosmetics Regulation 1223/2009, issued by the European Commission and ECHA (European Chemicals Agency).
In the EU there is a total ban on animal testing for cosmetic products and its raw materials, which the Cosmetics Regulation 1223/2009 reflects in its provisions.
This ban affects two aspects of cosmetic products:
– Testing Ban: any animal testing in cosmetic products or cosmetic raw materials cannot be conducted in the EU as of 11th September 2014 – following the ban on testing ingredients and their combinations in force since 11th March 2009
– Marketing Ban: cosmetics tested in animals, or whose ingredients have been tested on animals, cannot be placed in the EU market as of 11th March 2013 – following a previous almost total ban in force since 11th March 2009 Read more
SCCS Opinions: Carbon Black, Titanium Dioxide and Zinc Oxide
The Scientific Committee on Consumer Safety (SCCS)published recently the new Opinions SCCS/1515/13, SCCS/1516/13 and SCCS/1489/12, on the risk assessment of the nano-forms of Carbon Black, Titanium Dioxide and Zinc Oxide. The aim of these Opinions is to evaluate the impact on human health of these substances when used in cosmetics.
What are nanomaterials?
Nanomaterial means an insoluble material with one or more external dimensions or an internal structure, on the scale from 1 to 100 nm. Read more
Stricter labelling principles for sunscreens in Europe
The efficacy of sunscreen products and the way this efficacy is being claimed are important public health-issues that lead the European Commission to both mandating the Scientific Committee on Consumer Safety (SCCS) to revise the use of UV filters and to ensuring the implementation of the sunscreens Recommendation 2006/647/EC of the 22nd of September 2006. This recommendation covers the efficacy of sunscreen products and the claimsrelated and though it is not a directive or regulation, it is the main document to consider when placing sunscreen products on the EU market.
The Recommendation aims to standardize and simplify the way sunscreen products are labelled throughout Europe in order to help the consumer to compare products and choose the right product for a given exposure and skin type.
The EC considers appropriate to set out examples of claims which should not be made in relation to sunscreen products, precautions that should be observed, and usage instructions that should be recommended for some of the characteristics claimed. Read more