Microplastics are synthetic, water-insoluble polymer items smaller than 5 mm, which are of particular concern for the aquatic environment. The potential impact of microplastics on the (aquatic) environment and human health have generated concerns in Member States of the European Union and worldwide.
ECHA’s public consultations on the restriction dossier for intentionally added microplastics
The French Competent Authorities warns on the use of Phenoxyethanol in leave-on baby products and sets a new labelling requirement!
The substance Phenoxyethanol is a preservative frequently used in cosmetic products regulated in Annex V/28 of the Cosmetic Regulation (EC) n. 1223/2009. It corresponds to the CAS number 122-99-6 and is authorized in cosmetic products in a maximum concentration of 1.0%.
Cannabidiol update in CosIng under the EC Cosmetics Regulation 1223/2009
Time for an update on Cannabidiol
Use of cannabis in cosmetic products is getting more and more diffused. It is easy to spot numerous advertisements on these products, especially for products containing cannabidiol, but a lot of confusion persists on many different levels, from manufacturers to consumers. Therefore, we decided to step in and provide some clarification and an update on the matter.
Opinion of the Scientific Committee on Consumer Safety (SCCS) – Revision of the Opinion on hydroxyapatite (nano) in cosmetic products
In response to the concerns of the European Commission about potential absorption and entry of nanoparticles of hydroxyapatite into the cells when used in oral cosmetic products, the Scientific Committee on Consumer Safety (SCCS) was requested to provide a safety assessment of hydroxyapatite (nano). After making a detailed evaluation of the data provided in the submissions and scientific literature, the SCCS considered needle-shaped hydroxyapatite (nano) to be of concern due to its potential toxic effects and stated that it should not be used in cosmetic products.
The German Federal Institute for Risk Assessment (BfR) publishes opinion on highly refined mineral oils in cosmetics.
The BfR published in 2018 a risk assessment on the use of Mineral hydrocarbons (MOSH and MOAH) in cosmetic products. The assessment was performed according to method IP346, designed in the 1980s as a preliminary test to predict mineral oils carcinogenic potential, when in contact with the derma.
Is the new classification of salicylic acid impactful on cosmetic products?
Salicylic acid is listed as preservative in Annex V (entry 3) of Regulation (EC) n. 1223/2009, and its use is restricted to a maximum concentration of 0,5% (acid). For purposes other than inhibiting the development of micro-organisms, salicylic acid is also listed in Annex III (entry 98) to be used up to a maximum concentration of 3% (rinse-off hair products) and 2% for other products. If salicylic acid is not used as preservative, its function should be apparent from the presentation of the product. Except for shampoos, salicylic acid shall not be used for children under the age of three years.
After SCCS mandate on HEPB (Submission II) related to eye irritation was adopted on 24-25 October, a Preliminary Opinion has been released on 21st December 2018
On the occasion of its plenary meeting on the 24th and 25th of October, the Scientific Committee on Consumer Safety (SCCS) approved the mandate for a scientific Opinion on Ethylzingerone with INCI name ‘Hydroxyethoxyphenyl Butanone’ (HEPB) and the possibility of this substance to cause eye irritation. This Opinion on HEPB was requested by the European Commission.
ECHA publishes new report on nanomaterials in the European Union
The European Chemicals Agency (ECHA) has released a report – free to download in English here – to study the truthfulness of the data in the market for products with nanomaterials in the EU.
This document with the title “Critical review of the relevance and reliability of data sources, methods, parameters and determining factors to produce market studies on manufactured nanomaterials on the EU market” presents the view of the ECHA as a starting point of the industry, leading the way for further studies related with nanomaterials.
Fragrance Allergens in Cosmetic Products: new potential challenges for labeling compliance
On 26-27 June 2012 the Scientific Committee on Consumer Safety (SCCS) delivered an opinion SCCS/1459/11 on fragrance allergens in cosmetic products.
2-Biphenylol restriction amended in Annex V
2-Biphenylol (also known as o-Phenylphenol) is an antifungal agent and preservative – it is commonly used for post-harvest control of storage disease in fruits and also in cosmetics products as a preservative.
Chemicals Found To Be Non-Compliant with EU Rules
Chemicals have always been a debatable subject in terms of harm and legal compliance. According to a recent study by the German Federal Institute for Risk Assessment (BfR), 32% of the 1,814 substances authorised by the European Chemicals Agency (ECHA) under the REACH regulation have been found to be non-compliant. The types of chemicals implicated in the study can be found mostly in paints, packaging, furniture and building materials. Read more
New updates on the Poison Centres website: new support pages and a future PCN Portal
The Poison Centres website has been updated with new support pages in order to assist the industry to prepare and submit information on hazardous mixtures.
Important decrease on the use of plastic micro beads on cosmetic products
Plastic microbeads are man-made solid plastic particles, smaller than 5mm, that are intentionally added to some rinse-off personal care and cosmetic products used to exfoliate or cleanse. Read more
Obelis UK Ltd established!
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
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