N-methyl-2-pyrrolidone (NMP – EC 212-828-1, CAS 872-50-4) is used as a solvent and a surfactant in cosmetic products. It may enhance the dermal absorption of other cosmetic ingredients. The substance, classified as CMR category 1B, has recently been under scientific scrutiny by the Scientific Committee for Consumer Safety (SCCS) and the EU Competent Authorities.
NEW restriction in cosmetics: Methyl Pyrrolidone
Leave-on products containing MCIT-MIT
Some preservatives have been recently prohibited in cosmetic products to be made available on the European Union market. An example is Methylisothiazolinone (MIT) and the combination Methylchloroisothiazolinone / Methylisothiazolinone (MCIT/MIT), which have been banned in leave-on cosmetic products.
Selling Cosmetics in Portugal
Non-EU Manufacturers and their EU importers have to meet specific requirements to sell Cosmetic Products in Portugal in the context of Market Surveillance activities at Customs.
Cosmetic products and cannabis under the EC Cosmetics Regulation 1223/2009
The rising trend
Nowadays, cannabis products are gaining more and more popularity around the world and the same is true for their use in cosmetic products. However, this plant has many different compounds that can be used and it is necessary to understand which of its parts can be used legally.
Efficacy and Safety Claims: testing cosmetic products
Cosmetic claims are among the main elements defining a cosmetic product, directing consumers’ choices and differentiating products on the market.
Registering Cosmetic Products in Spain
The European Union is a complex system of different countries sharing regulations in order to harmonize their national legislations. However, while the EU is a coordinated entity, it does not have a single legislative system – there are some differences regarding specific matters, such as the placement of cosmetic products on the market.
Natural Substances in Europe: A new initiative to boost knowledge and safety
In September 2016 UNITIS, a European Organization of Cosmetics Ingredients Industries and Services, launched the NCS TOX Project in collaboration with the Botanical Alliance aiming to enhance the knowledge of natural substances in Europe. To achieve this, both associations together with 11 key actors in the botanical cosmetics industry decided to focus on creating a database of the toxicological profiles and testing information pertaining to natural substances.
Switzerland harmonizes Cosmetics Regulation with EU’s
Since June 2014, Switzerland’s food and consumer products’ regulations have undergone a complete revision. This was the result of Project LARGO, which had the goal of harmonizing Swiss laws with the European Union in order to open the market, uphold bilateral treaties and ensure a higher level of protection for consumers.
Do cosmetics sales on the Internet need to follow EU rules?
Cosmetics manufacturers need to be aware that selling their products on the Internet and thus making them available to the EU market subjects them to the same rules applicable to cosmetic products offered in physical stores in EU Member States.
Fragrances under scrutiny
Several Opinions were recently issued by the Expert Committees in regard to the use of fragrances in cosmetic products, as serious concerns were raised over their allergenic potential. Read more
Cyclopentasiloxane (D5) and Cyclotetrasiloxane (D4) restricted in the EU
Recently many ingredients have been restricted in cosmetic products, among others: Cyclopentasiloxane (D5) and Cyclotetrasiloxane (D4). Both of them are silicones, and they are used to protect the skin and to retain moisture.
In 2015, the Scientific Committee of Consumers Safety (SCCS) stated that the level of Cyclotetrasiloxane (D4) as an impurity of Cyclopentasiloxane (D5), should be kept as low as possible, due to the toxicity potential of D4.
At the beginning of 2017 the European Commission (EC) proposed to ban Cyclotetrasiloxane (D4) and Cyclopentasiloxane (D5) in rinse-off cosmetic products, with 0.1% or more of either substance. This ban, when officially published, is going to cover products such as shampoos, conditioners, shower gels, etc.
The European Chemicals Agency (ECHA) plans to go even further and to extend the restriction to leave on personal care products intended to remain on the skin. This proposal is currently in public consultation. Read more
Expiration date and PAO for Cosmetics
One of the crucial requirements towards cosmetic products is their safety for human health. The core element of the cosmetic safety compliance is the Safety Assessment, which includes (among others) stability testing. This specific test is aimed at evaluating the shelf life of the finished products or their Period After Opening (PAO). 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