Cosmetics & Personal Care | Summer Recap 2020

Eurofins newsflash Cosmetics and Personal Care

Regulatory news

Europe

New webpage on endocrine disrupting chemicals

In June 2020, National authorities in Belgium, Denmark, France, the Netherlands and Sweden launched a webpage on endocrine disrupting chemicals. The aim of the website is to compile information on these types of substances and, in this way, to outline their current status in Europe.

For further information , please visit the Endocrine Disruptor Lists website here.

Technical publications

Please find below a table summarising the most recent technical publications (non-exhaustive):

Date	Countries	Entity	Title
30/03/2020	Europe	European Commission	Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution, etc.)
01/04/ 2020	UK	The British Plastics Federation (BPF) The Cosmetic, Toiletry and Perfumery Association (CTPA) The Food and Drink Federation (FDF)	Industry publishes the following new guidelines: Recycled Content Used In Plastic Packaging Applications.
28/04/2020	France	ANSES	Sprays and diffusers based on essential oils: ANSES calls for vigilance
15/04/2020	France	DGCCRF	Labelling of your cosmetic products
15/04/2020	France	DGCCRF	Free claims in cosmetic products
26/05/2020	Europe	European Commission	List of National Competent Authorities for Cosmetics, Poison Centres and other relevant authorities.
28/05/2020	Germany	BfR (German Federal Institute)	Risk Assessment answers the most important questions on sun cream products. Sun cream protects, but are there health risks?
27/05/2020	France	CITEO	Hygiene-beauty packaging: sort them better, recycle them better
05/06/2020	Europe	ECHA ( European Chemical Agency)	20 EU Member States have reported an increase in non-compliant (hand) disinfectants in their markets since March 2020 to the ECHA and European Commission.
08/06/2020	Europe	ECHA ( European Chemical Agency)	Alternatives to animal testing continue to be widely used
10/06/2020	Europe	ECHA ( European Chemical Agency)	RAC backs restricting intentional uses of microplastics
22/06/2020	Europe	SCHEER (Scientific Committee on Health, Environmental and Emerging Risks)	Final Opinion on the potential for anaerobic biodegradability in marine and freshwater of Linear Alkylbenzene Sulphonates (LAS)
25/06/2020	France	DGCCRF (Direction générale de la concurrence, de la consommation et de la répression des fraudes)	Tattoo: what you need to know (in french)
25/06/2020	France	DGCCRF (Direction générale de la concurrence, de la consommation et de la répression des fraudes)	Solar products sheet.
20/07/2020	Germany	BfR (German Federal Institute)	Aluminium in antiperspirants: Low contribution to the total intake of aluminium in humans
30/07/2020	Europe	European Commission	Specific Privacy Statement for call for data on the ingredients ‘alpha and beta arbutin’ under Regulation (EC) 1223/2009
18/08/2020	Europe	ECHA ( European Chemical Agency)	New Board of Appeal decisions concerning vertebrate animal testing on cosmetic ingredients
01/09/2020	Europe	European Commission	Borderline products manual on the scope of application of the Cosmetics Regulation (EC) No 1223/2009 (Art. 2(1)(a))

France

Measures relating to the fight against the spread of COVID-19

In response to the COVID-19 pandemic, the French authorities published the following order in relation to hydro-alcoholic products:

JORF n ° 0083 of April 5, 2020 text n ° 2
Decree n ° 2020-396 of 4 April 2020 relating to the regime for controlling the sale prices of hydro-alcoholic gels during the health emergency.
JORF n ° 0083 of April 5, 2020 text n ° 4
Order of April 4, 2020 relating to the maximum sale price of hydro-alcoholic products prepared by pharmacies.
JORF n ° 0082 of April 4, 2020 text n ° 4
Order of April 3, 2020 amending the order of March 13, 2020 authorising by derogation the temporary availability on the market and the use of certain hydro-alcoholic products as disinfectant biocides for human hygiene
JORF n ° 0087 of April 9, 2020 text n ° 10
Decree of April 7, 2020amending the decree of March 6, 2020 authorising by derogation the provision on the market and temporary use of certain hydro-alcoholic products as disinfectant biocides for human hygiene
JORF n ° 0097 of April 21, 2020 text n ° 3
Order of April 17, 2020 amending the order of March 13, 2020 authorising by derogation the temporary availability on the market and use of certain hydro-alcoholic products as disinfectant biocides for human hygiene
JORF n ° 0089 of April 11, 2020 text n ° 7
Order of April 10, 2020 relating to the maximum sale price of hydro-alcoholic gels intended for personal hygiene packaged in special containers.
JORF n ° 0125 of May 23, 2020 text n ° 15
Order of May 19, 2020 amending the order of March 6, 2020 authorising by exemption the temporary availability on the market and use of certain hydro-alcoholic products as disinfectant biocides for human hygiene.

Regulatory updates

Please find below a table summarising recent regulatory proposals made to the European Commission (Non-exhaustive):

Countries

Notification number

Title

France

2020/329/F

Decree prescribing the general measures necessary to deal with the COVID-19 epidemic in the context of the state of health emergency.

Price control provisions for hydroalcoholic solutions and masks, requisition provisions or provisions relating to medicinal products.

Proposition 65: new fact sheets.

See below a list of new fact sheets available on the Proposition 65 website.

OTC monograph reform

On 27^th march 2020, the coronavirus aid, relief, and economic security act (CARES Act) was signed into law. This act covers measures for the over the counter (OTC) drug monograph process.

The CARES act also affects the sunscreen innovation act and permits the marketing of sunscreen drug products under the 1999 final monograph outlined in 21 CFR 352. This applies to non-prescription sunscreen active ingredients or a combination of such ingredients with new sunscreen active ingredients.

The FDA will be required to issue a new order within 18 months (by September 2021) as it relates to sunscreen products, which will have an effective date of at least one year thereafter.

Australia

Public consultation on isothiazolinones

In April 2020, Australia’s Department of Health initiated a consultation on ten proposed amendments to the existing Poisons Standard. The proposed amendments are:

Proposed amendments to scheduling advice for ACMS #31

Oxymetazoline
Eletriptan
Clotrimazole
Sildenafil
Ibuprofen
Cumyl-pegaclone

Proposed amendments to scheduling advice for the Joint ACMS-ACCS #25

Nicotine
Cannabidiol
Methylisothiazolinone and methylchloroisothiazolinone
Isothiazolinones

On 18th May 2020, the public consultation in relation to proposed amendments to the Poisons Standard closed. All public submissions have been published on the TGA website.

For more information, please visit the TGA website here.

New era in regulation of industrial chemical importation and manufacturing

From 1^st July 2020, AICIS (Australian Industrial Chemicals Introduction Scheme) is the new national regulator of industrial chemical introduction. The scope of the scheme covers chemicals, polymers and ingredients of products used in printing, plastics, mining, construction, paints, adhesives, consumer goods, cosmetics and many more.

An overview of the changeover and a full explanation of the transitional arrangement for the changeover from NICNAS to AICIS are available here.

For further information on AICIS, please visit AICIS’s website here.

Hand sanitisers and COVID-19

On 7^th May 2020, the Australian Therapeutic Goods Administration (TGA) published an urgent legislative instrument to relax regulations on hand sanitizer that contain ethanol or isopropyl alcohol.

The TGA’s website provide information to help manufacturers, suppliers and advertisers of hand sanitisers to understand their regulatory obligations under therapeutic goods legislation.

China

China's microbeads ban

On 10^th April 2020, the National Development and Reform Commission announced a public solicitation on the "Catalogue of Plastic Products Prohibited and Restricted from Production, Sales, and Use (Draft for Comment)" from April 10, 2020 to April 19, 2020.

The implementation of the "Opinions on Further Strengthening the Control of Plastic Pollution" seeks to refine policy boundaries and implementation standards for the prohibition of production, sales and use of plastic products in various fields. For example, rinse-off cosmetics (including bath lotion, facial cleanser, hand sanitizer, soap, shaving foam, body scrub, shampoo, hair conditioner, makeup remover/oil), toothpaste and tooth powder in which solid plastic particles are intentionally added with a particle size of less than 5 mm for the purpose of scrub, exfoliation and cleaning. It does not include plastic particles that result from the outer packing of the product.

On July 10, 2020 the NDRC released Notices [2020] No. 80 and [2020] No.1146 to give a detailed definition and scope of this prohibition.

China Released Cosmetic Supervision and Administration Regulation (CSAR)

On 29^th June 2020, the State Council of the People's Republic of China released the Decree No.727 of “Cosmetic Supervision and Administration Regulation”, this regulation will replace the current cosmetic regulations - Regulations Concerning the Hygiene Supervision over Cosmetics, which originally were first released in 1989 and implemented in 1990.

The CSAR covers six chapters, giving clear provisions for filing or registration of cosmetic ingredients and finished products, production and operation of cosmetics, labelling and advertisement as well as supervision over cosmetics throughout the supply chain. It also includes penalties for companies in violation.

The CSAR shall come into force as of January 1, 2021.

The complete notification can be found here (in Chinese).

International

Technical publications

Please find below a table summarising the most recent technical publications (non-exhaustive):

Date	Countries	Entity	Title
01/07/2020	Australia	Australian Government- Department of health	Ban on the use of animal test data for cosmetics
04/05/2020	International	IFRA (International Fragrance Association)	Guidance for the use of IFRA standards

Regulatory proposals notified to WTO

Please see the below table summarising the most recent notifications made to the World Trade Organization (non-exhaustive):

Notification number / Link	Country	Title
G/TBT/N/THA/574	Thailand	Notification of the Ministry of Public Health Re: Characteristics of cosmetic products containing alcohol for hand sanitisation that are may not be produced, imported or sold - B.E. 2563 (2020) This Notification determines the characteristics of cosmetic products containing alcohol for hand sanitisation that may not be produced, imported or sold.
G/TBT/N/KOR/895	Korea	Proposed Notification of "Regulation on Review for Establishment and Adjustment of Standards for Usage of Cosmetic Ingredients" The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea is adjusting the Standards for Usage of Cosmetic Ingredients" in the following ways: Designating cosmetic ingredients with usage restrictions (e.g. preservatives, sunscreens, colorants). The proposed regulation requires dossiers to be completed and filled (information on ingredients, usage status in or outside the country, safety and efficacy data, etc.) Safety data shall contain results from eleven types of tests, including skin irritation tests, toxicological tests, efficacy data, preservative efficacy tests results, etc.
G/TBT/N/CHN/1454	China	Provisions for Cosmetics Registration
G/TBT/N/CHN/1453	China	Provisions for the Supervision and Administration of Cosmetics Production and Distribution
G/TBT/N/AUS/122	Australia	Consumer Goods (Cosmetics) Information Standard 2020

Product Recalls / Alerts

Below you will find a monthly summary of product recalls and alerts in Europe (Source “RAPEX”) and in the US (Source “CPSC”).

Europe

RAPEX (European Commission Rapid Alert System for dangerous non-food products – Alerts reported by EU national authorities).

The following 5 alerts regarding Cosmetic and Personal Care products have been reported, from week 16 to week 20 of 2020.

Type of Risk	Number of alerts	Notes
Chemical	2	Manicure pen: The product contains methylisothiazolinone (MI).
Chemical	2	Tattoo ink: The product contains nickel.
Microbiological	3	Mascara: The product contains an excessive amount of mesophilic micro-organisms.

The following 17 alerts regarding Cosmetic and Personal Care products have been reported, from week 21 to week 26 of 2020.

Type of Risk	Number of alerts	Notes
Chemical	10	Perfume: contains substances, which can induce allergic reactions and sensitisation, which are not indicated in the list of ingredients.
		Baby wet wipes: contains a mixture of the preservatives methylchloroisothiazolinone and methylisothiazolinone (MCI and MI), which are forbidden in leave-on cosmetics.
		Hand disinfectant: contains an insufficient amount of ethanol and propan-2-ol.
Fire/Health risk	5	Hand disinfectant: the presence of ethanol is not accompanied by the required corresponding hazard pictograms and warnings. Users have therefore no information on the flammability of the product, which in the presence of an ignition source, could lead to a fire. The product contains an insufficient amount of ethanol. Consequently, it might not kill bacteria or viruses, which could then reach the user, increasing the risk of infection.
Health risk	1	Sunscreen: product lacks UV filters and its actual protection factor is lower than indicated.
Health risk	1	Perfume: is counterfeit and lacks the compulsory human health safety evaluation.

From the 16^th April 2020 to the 20^th May 2020, the CPSC (Consumer Product Safety Commission) has published the following recalls: 10 recalls regarding Cosmetic and Personal Care products.

Type of Risk	Number of alerts	Notes
Poisoning	10	Essential oil: It contains the substance methyl salicylate which must always be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA).

From the 21^th May 2020 to the 30^th June 2020, the CPSC (Consumer Product Safety Commission) has published the following recalls: 4 recalls regarding Cosmetic and Personal Care products.

Type of Risk	Number of alerts	Notes
Poisoning	4	Essential oil: contains the substance methyl salicylate which must always be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA).