On 13 December 2019, the Scientific Committee on Consumer Safety (SCCS) published an opinion on the use Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate. In its opinion, the SCCS concluded that the substance is safe for use in cosmetics at a maximum concentration of 3 %. The SCCS did not assess inhalation toxicity, hence the opinion is not applicable to cosmetic products that could lead to exposure of the end-user’s lungs by inhalation.

Annex VI is therefore amended as follows:

Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate:

• Max concentration in ready for use preparation: 3%
• Conditions:
  • Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation
  • Do not use with nitrosating agents – Maximum nitrosamine content: 50 μg/kg
  • Keep in nitrite-free containers

This Regulation will enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

2. Hair dye ban and restrictions
3. Based on the safety assessment of hair dye substances by the SCCS, they concluded that it is necessary to prohibit the use of three hair dye substances:

• 1,2,4-Trihydroxybenzene,
• 2-[(4-Amino-2-nitrophenyl)-amino]-benzoic acid,
• 4-Amino-3-hydroxytoluene.

These substances will therefore be added to Annex II of Regulation 1223/2009.

From 3 September 2021 hair and eyelash dye products containing those substances shall not be placed on the Union market.

From 3 June 2022 hair and eyelash dye products containing those substances shall not be made available on the Union market.

1. In light of the final SCCS opinions on other six hair dye substances: Dimethylpiperazinium Aminopyrazolopyridine HCl, Methylimidazoliumpropyl p-phenylenediamine HCl, HC Orange No 6, Acid Orange 7, Tetrabromophenol Blue and Indigofera Tinctoria, it was concluded that their concentration in hair dye products should be restricted.

1. The SCCS also evaluated the use of the substance 2-Methoxymethyl-p-Phenylenediamine and its sulfate (currently listed under entry 292 in Annex III) on eyelashes. Based on that opinion, the field of application of the restriction to which they are subject should be extended to products intended for colouring eyelashes. Additionally, the latter products should be allowed for professional use only

Furthermore, appropriate warnings should be printed on the labels of hair dye products in order to inform consumers and professionals about possible adverse effects of hair dyes and products intended for colouring eyelashes.

The exact restrictions, warnings and date of effect of these restrictions can be found here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2020.379.01.0034.01.ENG#ntr*1-L_2020379EN.01003601-E0001

3. HEMA and DI-HEMA Trimethylhexyl Dicarbamate restriction

The SCCS concluded in its opinion that HEMA and DI-HEMA Trimethylhexyl Dicarbamate (Di-HEMA TMHDC) are not likely to pose a risk of sensitisation when  applied appropriately to the nail plate and there is no contact with the adjacent skin.

However, in some Member States, there have been cases of sensitisation to nail product containing HEMA and Di-HEMA TMHDC. Based on this, the EU Commission concluded that there is a risk of skin sensitisation as a result of insufficient precision when applying these products. Therefore, such products can come into contact with the skin adjacent to the nail plate.

Since the use of nail products containing HEMA and Di-HEMA TMHDC by professionals is expected to be safer for the users, such products are restricted to professional use only. Furthermore, these products require the addition of the following warning – ‘’can cause an allergic reaction’’.

From 3 June 2021 products containing either one of the two substances and not complying with the conditions set out Annex III (entries 313 and 314), shall not be placed on the Union market.

From 3 September 2021 products containing either one of the two substances and not complying with conditions set out in Annex III (entries 313 and 314) shall not be made available on the Union market.

The post The EU Commission amends Annexes II, III and VI to Regulation (EC) No 1223/2009 on cosmetic products appeared first on CE.way.

This newly published technical document complements the Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants as well as Borderline Manual (Manual of the Working Group on Cosmetic Products (Sub-group on Borderline Products) on the Scope of the Application of the Cosmetics Regulation (EC) No 1223/2009).

The technical document points out that although the classification of each product should be done on a case-by-case basis, taking into consideration all characteristics, product claims can be a strong indication of the main purpose of the product.

The guidance provides a list of claims, references or allusions and pictures or graphical elements that would not support a main cosmetic function of leave-on hydro alcoholic hand gels.

Below are the labelling elements (examples from the guidance) which are not appropriate for cosmetic products and would cause the perception that a hand gel has mainly a biocidal function.

Claims (and their variations):

• antibacterial, antimicrobial, antiviral, virucide, antifungal (and their attributes, such as

‘antiviral properties’, ‘antibacterial ingredients’, ‘inhibits bacterial growth’);

• disinfecting, disinfectant, disinfection, sanitizer, sanitizing;
• antiseptic;
• kills X% bacteria/viruses/microbes;
• decontaminating;
• formulation recommended by the World Health Organisation (WHO);
• anti-COVID-19, anti-coronavirus, anti-SARS.

References or allusions to:

• infection, pandemic, diseases;
• COVID-19, coronavirus, SARS-CoV-2;
• microorganisms, bacteria, viruses, pathogens, germs, fungi;
• disinfection;
• medical use;
• percentage of alcohol in the product;
• safe hands.

Pictures or graphical elements of:

• (corona)virus, bacteria, microbes;
• (red) cross (when suggesting a medical connotation);
• shield (when indicating protection against microorganisms);
• STOP sign (when indicating preventing/controlling the spread of a disease or infection or microbes);
• any sign related to hospital, pharmacy, ambulance, first aid, etc;
• CLP pictograms.

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The law will apply from January 1, 2025, and it will prohibit the manufacturing and sale of any cosmetic products that contains any of the following 12 intentionally added ingredients:

(1) Dibutyl phthalate (CAS no. 84-74-2).

(2) Diethylhexyl phthalate (CAS no. 117-81-7).

(3) Formaldehyde (CAS no. 50-00-0).

(4) Paraformaldehyde (CAS no. 30525-89-4).

(5) Methylene glycol (CAS no. 463-57-0).

(6) Quaternium-15 (CAS no. 51229-78-8).

(7) Mercury (CAS no. 7439-97-6).

(8) Isobutylparaben (CAS no. 4247-02-3).

(9) Isopropylparaben (CAS no. 4191-73-5).

(10) m-Phenylenediamine and its salts (CAS no. 108-45-2).

(11) o-Phenylenediamine and its salts (CAS no. 95-54-5).

(12) The following per- and polyfluoroalkyl substances (PFAS) and their salts:

• Perfluorooctane sulfonate (PFOS); heptadecafluorooctane-1-sulfonic acid (CAS no. 1763-23-1).
• Potassium perfluorooctanesulfonate; potassium heptadecafluorooctane-1-sulfonate (CAS no. 2795-39-3).
• Diethanolamine perfluorooctane sulfonate (CAS 70225-14-8).
• Ammonium perfluorooctane sulfonate; ammonium heptadecafluorooctanesulfonate (CAS 29081-56-9).
• Lithium perfluorooctane sulfonate; lithium heptadecafluorooctanesulfonate (CAS 29457-72-5).
• Perfluorooctanoic acid (PFOA) (CAS no. 335-67-1).
• Ammonium pentadecafluorooctanoate (CAS no. 3825-26-1).
• Nonadecafluorodecanoic acid (CAS no. 355-76-2).
• Ammonium nonadecafluorodecanoate (CAS no. 3108-42-7).
• Sodium nonadecafluorodecanoate (CAS no. 3830-45-3).
• Perfluorononanoic acid (PFNA)(CAS no. 375-95-1).
• Sodium heptadecafluorononanoate (CAS no. 21049-39-8).
• Ammonium perfluorononanoate (CAS no. 4149-60-4).

However, this does not apply to cosmetic products, which contain technically unavoidable trace quantity of an ingredient listed above, that comes from impurities of natural or synthetic ingredients, manufacturing process, storage, or migration from packaging.

The list of banned ingredients is consistent with the EU’s Annex II of Regulation No. 1223/2009, which includes substances prohibited for use in cosmetics sold in the EU. Among those are also the 12 substances prohibited by California’s Toxic-Free Cosmetics Act.

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The new regulation will be implemented on January 1, 2021. Following the release of CSAR, China will publish a series of supporting documents and administrative rules, which will further establish China’s cosmetic regulatory framework.

To ensure a smooth transition, a five-year grace period was granted for hair growth, hair removal, breast beauty, slimming and deodorant products, which were already registered.

The new regulation brings many changes, below are some of the highlights:

• unified filing system for domestic and imported non-special use cosmetics (now referred as general cosmetics)
• new cosmetic ingredient registration and management
• new rules on efficacy testing and claim substantiation
• safety risk assessment and exemption from mandatory animal testing

Updated product categories

Toothpastes are now considered general cosmetics and are regulated under CSAR. However, soaps remain outside of scope of CSAR, with the exception of soaps with special cosmetic efficacy.

Cosmetic products are referred to as general cosmetics and special use cosmetics. The latter include hair dyes, hair perms, whitening products, sunscreen products, anti-hair loss products and products with new efficacies. These are all subject to pre-market registration. On the other hand, general cosmetics include all other cosmetic products and only require filing.

New cosmetic ingredient management

Cosmetic ingredients are classified as ‘’new’’ and ‘’used’’ ingredients. New ingredients with high risk, such as preservatives, sunscreens, whitening agents, colorants, and hair dyes require registration and approval from the National Medical Products Administration (NMPA). Other new ingredients are subject to filing with NMPA.

Cosmetic efficacy claims

Cosmetic claims must be substantiated by sufficient scientific evidence, which will be made publicly available on the NMPA’s website.

Safety assessment and animal testing

General cosmetics will no longer be subject to mandatory animal testing, whether they are produced domestically or imported into China. Safety assessments will be accepted in place of animal testing. However, there are some exceptions, which will still require animal testing:

• products intended for use by children or infants
• products with new ingredients, which have been approved but are not yet listed in the IECIC

Additional requirement for imported cosmetics

Imported cosmetic products also need to submit certifications relating to manufacturing quality control of the overseas manufacturers as well as documents, that prove those products have been placed on the market in the country of origin. For products, which are specifically produced for China, the applicant must provide research and test data for Chinese consumers.

The post China released the final version of Cosmetic Supervision and Administration Regulation (CSAR) appeared first on CE.way.

The SCCS also published the final opinion on the use of aluminium in antiperspirants and cosmetic products and the final opinion on the use of zinc pyrithione for anti-dandruff products. These were both adopted on March 3-4, 2020.

Hair dye – Indigofera tinctoral

The committee considers the hair dye ingredient Indigofera tinctoral to be safe when used in non-oxidative condition hair colouring products at on-head concentrations of up to 25%.

The SCCS did, however, add that a weak skin sensitisation potential cannot be excluded for this ingredient.

The safety of aluminium

The SCCS evaluated the safety of aluminium when used in antiperspirants and other cosmetic products such as toothpastes and lipsticks. They consider the use of this ingredient safe at the following concentrations:

• 6.25% in non-spray deodorants or non-spray antiperspirants,
• 10.6% in spray deodorants or spray antiperspirants,
• 2.65% in toothpaste, and
• 0.77% in lipstick.

Additionally, the SCCS said that ‘’ The systemic exposure to aluminium via daily applications of cosmetics does not add significantly to the systemic body burden on aluminium from other sources’’. However, the committee acknowledged that they have not taken into account the daily dietary intake of aluminium, which is the major source of aluminium in the population.

Anti-dandruff ingredient – Zinc pyrithione

Based on the final opinion on the safety of zinc pyrithione, the SCCS considers the ingredient to be safe when used as an anti-dandruff in rinse-off hair products up to a maximum concentration of 1 %. This consideration is in line with the conditions laid out in Article 15 (d) of the Cosmetics Regulations (EC) No. 1223/2009 and takes into account all the scientific data provided.

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Dihydroxyacetone is currently not regulated under the Cosmetics Regulation 1223/2009 but based on the available data on the safety of this substance, the SCCS concluded that the use of DHA as a hair colouring ingredient in leave-on, non-oxidative applications up to a maximum concentration of 6.25 %, will not pose a risk to the consumer’s health. Furthermore, the substance is considered safe for use in self-tanning lotions and face creams containing up to a maximum concentration of 10 % DHA.

SCCS Preliminary opinions

The SCCS currently has its preliminary opinion on the safe use of hair dye Indigofera tinctoria (C170) open for comments until 13 March 2020. They are considering the safety of the substance when used in non-oxidative condition hair colouring products as on-head concentrations of up to 25%. Additionally, the SCCS noted that a weak skin sensitisation potential cannot be excluded for this substance.

SCCS Opinions being finalized

The SCCS is finalizing its opinion on the safety of aluminium in cosmetic products. In the light of the new data provided, the second preliminary opinion suggests that the use aluminium at 6.25% in non-spray antiperspirants and 10.6% in spray antiperspirant, is safe.  The use of aluminium in other cosmetic products, such as toothpaste and lipstick, is suggested to be safe at the concentrations of 2.65% and 0.77%, respectively.

The post Final opinion on the safety of dihydroxyacetone (DHA) appeared first on CE.way.

Background

The European Commission issued a proposal for classification of titanium dioxide as a suspected carcinogen of category 2 by inhalation on 4 October 2019.  This decision followed a scientific opinion of 14 September 2017, published by ECHA’s Committee for Risk Assessment (RAC).

The recently accepted proposal has faced opposition from the industry, arguing that the classification of titanium dioxide as a carcinogen is not related to substance’s chemistry but rather the physical characteristics of the particles, such as shape and size of the particles and poor solubility – characteristics not specific to titanium dioxide but rather shared with many other substances.

New requirements

The Regulation sets out a requirement of cancer warning labels for mixtures in powder form containing 1% or more of titanium dioxide particles with an aerodynamic diameter of ≤ 10 µm. Although, other forms and mixtures do not fall under this classification, there are specific warnings that need to be applied to those that contain more than 1% of titanium dioxide.

However, under Cosmetic Regulation (EC) No 1223/2009, a substance classified as CMR substance of category 2, under Regulation (EC) No 1272/2008, is prohibited for use in cosmetic products, unless an exemption applies. That means sunscreen products and other cosmetic products which contain titanium dioxide and pose a risk of inhalation by the consumer may not be allowed on the EU market.

In light of the recent classification of the substance as a carcinogen, the Scientific Committee on Consumer Safety (SCCS) will reconsider the safety of titanium dioxide. On 5 February, the SCCS issued a request for a scientific opinion on titanium dioxide used in cosmetic products and now has six months to prepare its opinion. According to the Cosmetic regulation, a category 2 substance is permitted in cosmetic products, if the SCCS has evaluated the substance and found it safe for use.

The Regulation will enter into force 20 days after its publication in the Official Journal of the European Union and will apply from 9 September 2021.

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What does this mean for your EU and UK cosmetics compliance and of course sales of your cosmetic products? Initially, nothing changes. After Brexit, there will be a transitional period when the EU and the UK will try to agree on the future trade relations, and that transitional period will last till the end of the year (although it will quite likely be extended by another year or 2). Till the end of the transitional period, the CPNP notifications and the EU RP are still valid for the UK as well, and the UK RPs can still act as the EU RPs.

After the transitional period ends though, you’ll need to get a UK based responsible person, do the UK product notification and make some changes on the labels, specifically:
– add the UK responsible person name and address
– since the UK will become a third country, products produced there and sold in the EU, will need to state “made in the UK” and vice versa for the products made in the EU

What are the timelines to appoint the UK RP, make the UK notification and update the labels?
– UK RP will have to be appointed at least till the end of the transitional period
– UK notification will have to be done in up to 3 months after the end of the transitional period
– Labels will have to be updated in up to 2 years from Brexit

Besides that, the cosmetics legislation in the EU and in the UK will remain the same for now. Future changes in the legislation may happen though.

CE.way has set up a subsidiary in the UK last year, so we can provide also the UK RP service and can do UK product notifications (once the UK notification portal becomes operational, at the moment it doesn’t exist yet). Contact us to get an offer if you’re interested in these services.

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Salicylic acid

Salicylic acid (2-hydroxy-benzoic acid) has been classified as a CMR substance of category 2 but it fulfils conditions laid down in Article 15 of the Cosmetics Regulation and can therefore be used according to the restrictions.

Salicylic acid and its salts are currently listed in Annex V to Regulation 1223/2009 and are allowed for use in a concentration of up to 0.5 % (acid). Additionally, salicylic acid is also listed in Annex III and can be used for purposes other than preservative. In this case it can be used in rinse-off hair products in a concentration of up to 3% and in other products in up to 2 %. It is not allowed to be used in preparations for children under 3 years of age, except for shampoos.

Based on the SCCS scientific opinion on Salicylic acid, which was published on 21 December 2018, as well as classification of salicylic acid as eye irritant and as a CMR substance of category 2, the following amendments to current entries of ‘salicylic acid’ should be adopted:

• Salicylic acid and its salts are allowed for use as a preservative in a concentration up to 0.5 % (the currently allowed concentration), except for oral products, applications that may lead to exposure of end-user’s lungs by inhalation and products for children under 3 years of age.
• Salicylic acid is allowed for non-preservative use in:
  • Rinse-off hair products in a concentration of up to 3 % (the currently allowed concentration)
  • Other products, except for body lotion, eye shadow, mascara, eyeliner, lipstick and roll-on deodorant applications, in a concentration of up to 2 % (the currently allowed concentration)
  • It is not allowed to be used in oral products, in applications that may lead to exposure of end-user’s lungs by inhalation and in products for children under 3 years of age

Other substances

Substance Oxyquinoline has been classified as CMR substance of category 1B, while its sulphate form has not been classified as a CMR substance. Therefore, Oxyquinoline sulphate should be listed in Annex III and allowed for use in cosmetic products under the restrictions laid down in Annex III.

Additional 19 CMR substances or groups of CMR substances have been added to Annex II. One of these substances, disodium octaborate anhydrous will be added to the group of substances, which are already listed in Annex II.

The Commission Regulation was published in the Official Journal of the European Union, on 28 November 2019 and has entered into force twenty days later.

The full text of the regulation update can be seen here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2019.307.01.0015.01.ENG&toc=OJ:L:2019:307:TOC

The post New amendments and corrections to Annexes II, III and V to Regulation (EC) No 1223/2009 appeared first on CE.way.

• the Food and Drugs Act and the Cosmetic Regulations
• the Consumer Packaging and Labelling Act and Consumer Packaging and Labelling Regulations
• the Hazardous Products Act and the Consumer Chemicals and Containers Regulation

The Food and Drugs Act and the Cosmetic Regulations regulate the classification and labelling of cosmetics. They also address the issues of product safety, composition and advertising. The Cosmetic Regulations also include warnings and symbols that need to appear on pressurized containers.

The Consumer Packaging and Labelling Act and Regulations prescribe information that must appear on the label of a product. Furthermore, the Act and Regulations also address false or misleading representation of the cosmetic product.

Canadian cosmetics legislation has rules on where certain information has to appear on the labelling. It is, therefore, important to be familiar with the terms such as principal display surface (PDS), principal display panel (PDP), inner label and outer label.

It is important to know that, some information listed on the label has to appear both in English and French.

Information that needs to appear on the PDP:

• Product identity (unless it is obvious): Common or generic name of cosmetics, or a statement of a cosmetic’s function has to appear both in English and French.
• Net quantity (in metric units). It is important to note that there needs to be a space between the number and the metric symbol or word. If written in words, it has to appear both in English and French.

Other information that needs to appear on the label:

• Name and address of the manufacturer/Canadian dealer: Can appear anywhere on the outside surface of the package, except on the bottom. May appear in English, French or both.
• Avoidable hazards and cautions: If any avoidable hazards are associated with the use of a product, the label has to include warnings on how to use the product to eliminate the risk (instructions for use, cautions, symbols etc.) Regulation includes precautions that have to be included on the label of the following products: hair dyes, mercury containing products, genital deodorants in pressurized containers, pressurized metal containers, flammable products in pressurized metal containers and mouthwashes. Warnings have to appear both in English and French.
• Ingredient list: Ingredients with the concentration above 1 % have to be listed in a descending order of predominance. Ingredients with a concentration below 1% can be listed in any order after those with a concentration above 1%. Fragrances or flavours have to be listed using the words “perfume” or “aroma”. Colouring agents should be listed as CI numbers of colour names (formerly FD&C names). Ingredients that are listed in the schedule of the Cosmetic Regulations (Appendix 1) can either be listed by their EU trivial names or by the appropriate English and French equivalents, or all 3 terms may be used together.

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