We are happy to inform you that on 27th of December Obelis has officially established a new company in the UK – Obelis UK Ltd. The purpose of this company is to serve as a UK Responsible Person for our clients, who will need a representative in the UK in the case of a ‘no deal’ Brexit. Read more
Obelis UK Ltd established!
EC Report on legitimate animal testing alternatives in cosmetics
SCCS opinion on the safety of cosmetic ingredient Phenylene Bis-Diphenyltriazine
The Scientific Committee on Consumer Safety (SCCS) first assessed the safety of phenylene bisdiphenyltriazine (S86) as a UV filter in sunscreen products in a concentration of up to 10% back in 2015, concluding that it could have genotoxic and phototoxic potential and that an adequate physico-chemical characterization should be provided. Read more
Critical ALERT (!) – EU Official Notice on BREXIT
On November 29th 2018, the European Commission (Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs) published an official notice to stakeholders in reference to NEW EU rules in the field of cosmetic products in relations to the Withdrawal of the United Kingdom from the European Union.
New intended bans on the use of preservatives in cosmetics have been notified to the WTO
The European Union has notified the WTO the amendments of its draft Regulation on April 24th, 2018, “draft Commission Regulation amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products”. The amendments notified concern the ban on the use of sodium o-phenylphenate, potassium o-phenylphenate and MEA o-phenylphenate as preservatives. Read more
The three forbidden Tagetes
Regulation (EU) 2018/978 of 9 July 2018 amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products has prohibited the use of Tagetes erecta flower extract, Tagetes erecta flower oil and of Tagetes minuta, patula extracts and flower oils in cosmetic products. Read more
The safety of nano Styrene/Acrylates copolymer and nano Sodium Styrene/Acrylates copolymer still raises question marks
“Nanomaterial” means an insoluble or biopersistent and intentionally manufactured material on a scale from 1 to 100 nm. According to Article 16 of the Regulation (EC) No 1223/2009 any cosmetic product containing nanomaterials shall be notified to the European Commission six months prior to their placement on the EU market. Read more
The updated technical document on cosmetic claims limits the use of “free of” claims
On 3rd of July 2017 the sub-working group on claims released the updated Technical document on cosmetic claims. The document serves as a collection of best practices and aims at providing guidance for the application of Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products. As of 1st of July 2019 the guidance related to “free from” and hypoallergenic claims should become applicable to all Member States. Read more
MBBT (nano) is now approved for use in cosmetic products
The European Commission has amended Annex VI of the Cosmetics Regulation in June this year in what concerns the entry of the nano-sized UV filter called Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (MBBT). Read more
Climbazole opinion has been published on the SCCS website
An Addendum to the opinion on Climbazole has been recently published by the Scientific Committee on Consumer Safety (SCCS) of the European Commission. Read more
The future of the Cosmetics Regulation
During this year’s Cosmetics Europe Annual Conference – a year event that gathers cosmetics leaders, experts, companies and regulators – the European Commission expressed where their concerns would lie for the future.
The updated risk assessment of substances used in cosmetics: the new evaluation of ECHA
Since the risk evaluation evolves together with the scientific innovation, Member States investigate certain substances to clarify whether their use poses a risk to human health or the environment. In most cases, the substances are of concern for their potential of being persistent and bio accumulative, to cause endocrine disruption, or to present carcinogenic, mutagenic and/or reprotoxic properties.
Sanitary Certificates for Cosmetics in Italy
Following the COUNCIL OF MINISTERS DECREE OF THE 4th NOVEMBER 2010, No.242, shipments of items that can be in touch with human beings, like Cosmetic products, coming from third countries and arriving at the international entry points of the Italian territory are subject to controls by the Italian Customs (USMAF-SASN). The control will physically inspect the goods, but showing a specific mandatory document will also be required.
New database on toxic values developed by the French National Authority on Health
Obelis visiting Cosmoprof Las Vegas
From the 29th to 31st of July 2018, the Obelis team of experts visited Las Vegas, in the USA, to deepen relationships with our clients and discuss about upcoming projects. During our stay in Las Vegas, Obelis exhibited at Cosmoprof North America, where not only we met many of our clients but also numerous manufacturers and producers of the cosmetics industry interested in our compliance services.
New amendments to the Cosmetics Regulation
Ex-vivo tests: cosmetics without human testing
The cosmetic industry has faced a complete regulatory revolution in the last 20 years. The change from the European Directive to the Regulation in 2009, increasing the safety requirements for cosmetic products, centralizing the notification of all cosmetics products placed on the EU market or the introduction of a “responsible person” was a unique milestone for the cosmetics industry. The EU showed an increasing awareness of the products circulating on the European market and how are they produced and tested. The framework has naturally developed under the social pressure against animal testing, which was banned in the EU in 2013.
Not only UVA and UVB: how cosmetics protect from blue and infrared light
The wide use of screens, smartphones and tablets expose the skin to the impact of blue light, which can lead to erythema, free radical production and long-lasting hyperpigmentation. Since current chemical filters cannot protect from blue light, cosmeticians can implement the protective function of cosmetics’ formulas by adding mineral filters, or anti-oxidants to limit accelerated skin ageing. Read more
Israel aligns with European cosmetics law
Silicones on the spot – again
From Asia Pacific to West: the antipollution claims in cosmetics are going global
According to the World Health Organization 92% of the world’s population lives in places where air pollution exceeds guideline limits.
Antipollution cosmetics, a well-established trend in Asia Pacific, are now going global due to the growing consumer awareness of the harmful effects of air pollutants on the skin, such as cellular damage, dryness, inflammation, pigmentation and premature aging.
Preservatives in cosmetics
Cosmetic and beauty products are made up of ingredients that are biodegradable, and therefore easily inhabited by micro-organisms. Substances destined to perform an effective action against microorganisms in cosmetic products are classified as preservatives.
New SCCS Opinion on Titanium Dioxide (nano form) as UV-Filter in sprays
As the presence of nanomaterials in cosmetic products is becoming more and more frequent, their safety is now being questioned more than ever. Before their use in cosmetics, they must be first authorized by the European Commission which will rely on the opinion from the SCCS (the Scientific Committee on Consumer Safety), responsible for reviewing such raw materials.
NEW restriction in cosmetics: Methyl Pyrrolidone
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.
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