chemicals in cosmetics and personal care products

Chemicals Chemicals in Cosmetics and Personal Care Products | 1

Chemicals in Cosmetics and Personal Care ProductsNews and insight from around the world

2 | Chemicals Chemicals in Cosmetics and Personal Care Products

More robust personal care and cosmetics legislation is taking shape around the world. From China’s new cosmetics regulation, to consumer- and regulator-driven campaigns for safer alternatives, and greater scrutiny of products that threaten biodiversity, we are entering a new era in the management of cosmetics, personal care products and ingredients.

Successful compliance requires an understanding of how cosmetics and personal care regulation is evolving, alongside how products are defined – products considered cosmetics in the EU, for example, could be defined as over-the-counter drugs in the US.

Chemical Watch’s award-winning news and insight coverage, along with our world class compliance tools and unparalleled events and training programmes, are designed to arm you with the information and skills you need to meet, and exceed, your compliance goals in cosmetics and personal care.

In this report, you will find a selection of recent news articles from our news and insight team, including regulatory and business developments that directly affect the cosmetics and personal care sectors. We have also included an excerpt from one of our in-depth Expert Focus articles, which looks at China’s changing cosmetics regulation.

We hope you enjoy this sample of Chemical Watch content. If you have any questions, or want to find out more about how we help customers ensure cosmetics and personal care compliance, feel free to get in touch.

The Chemical Watch team

Introduction


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Contents

5 Sephora to restrict six further substance groups from March 2022

7 US FDA proposal repeats data call for sunscreen ingredient review

9 California updates list of reportable cosmetic ingredients

10 Mexico passes complete ban on cosmetics animal testing

11 Danish tests reveal potential harm from private-use tooth whitening products

12 European Parliament adopts resolution calling for action plan to phase out

animal testing

14 France edges closer to selling non-animal tested cosmetics in China

16 Australia investigating substances of concern in sunscreens

18 Thailand bans sunscreens containing coral-harming chemicals from

national parks

19 What does China’s new cosmetic regulatory framework mean for business?

News and Insight: coverage highlights

Expert focus


Beauty products multinational, Sephora, has added multiple substance groups to its ‘formulated without’ list, redoubling efforts to help businesses move to safer formulations.

Substance groups added to the ‘Clean at Sephora’ scheme in July are:• per- and polyfluoroalkyl substances

(PFASs), which boost cosmetics’ durability and water resistance;

• octinoxate, which offers sun protection;

• nitromusks and polycyclic musks, which impart scent;

• cyclic silicones, which serve as emollients and solvents;

• ethylenediaminetetraacetic acid (EDTA) and derivatives, which act as chelating agents; and

• ethoxylated ingredients, such as polyethylene glycols (PEGs), which function as surfactants, emulsifiers, cleansers and moisturisers.

Businesses producing items with the Clean at Sephora seal have been

required to avoid the first three groups since 31 July. Fragrance makers have until March to remove these ingredients, but Sephora did not elaborate on the reason for this extension. Restrictions on the remaining groups will take effect then as well.

While the multinational will prohibit cyclic silicones, it will permit small amounts of EDTA and ethoxylated ingredients in certain cases.

The restrictions build on the retailer’s 2019 chemicals policy, which committed to halve by 2022 total offerings with nine substance groups industry and environmentalists have identified as high priority. According to a progress update released last month, the company has so far reduced stocks of such items by roughly 30%, and is engaging with producers to aid them in understanding which goods follow its guidelines.

Launched in 2018, the Clean at Sephora scheme has since almost doubled in

size, now covering more than 90 lines and 50 substance classes, the retailer told Chemical Watch. This summer, it established ‘Clean + Planet Positive’, which “further identifies clean brands on a mission to change the beauty landscape” via climate, packaging, sustainable sourcing and environmental giving criteria.

Sustainable sourcing entails microplastic- and cruelty-free goods, and the packaging specifications require using ‘no unnecessary materials’, and exploring biomaterials and plant-based ink.

Additionally, Sephora said nearly 100% of its non-fragrance articles now provide ingredient information on its website – hitting the corporation’s target for 2020.

More action needed

Perfume manufacturer 7 Virtues has been a Clean at Sephora member since the start. According to CEO Barb

Sephora to restrict six further substance groups from March 2022PFASs, octinoxate and cyclic silicones among those added to ‘clean’ scheme

24 August 2021

News and Insight: coverage highlights

Read samples and extracts of recent articles affecting the cosmetics and personal care sectors

Global

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Stegemann, its items never contained substance groups on Sephora’s restricted list.

Joining the initiative “was constructive”, Ms Stegemann said, “as I had been doing this solo with no mentorship or guidance on clean beauty but knew instinctively this was something important to our DNA”. Today, she said, “every time Sephora adds new requirements, we return to our chemists and update to follow their standards,” including packaging considerations.

Susteau, another Clean at Sephora participant, said its motivation for entering the programme was “working with a retail partner who shared a

similar view on the future of clean, which included a product’s impact on the environment”. The haircare manufacturer added that its offerings, too, had always aligned with the seller’s ‘formulated without’ specifications “as this was core to our brand”.

Mike Schade, Safer Chemicals, Healthy Families’ Mind the Store campaign director, said “Sephora has continued to demonstrate substantial leadership in addressing harmful chemicals in their supply chain.” He noted its “substantive progress” over the past year, particularly since the NGO began assessing the corporation through Mind the Store’s retailer report card.

Clean at Sephora’s ban on PFASs “is a big deal”, Mr Schade said, but “the company should set a new goal to reduce and eliminate PFASs in all private-label and brand-name cosmetics”.

And it should collaborate with suppliers “to publicly disclose fragrance ingredients and ensure no other hidden toxic chemicals such as phthalates are present in fragrance formulations”, he said. “Customers have a fundamental right to know what’s in the products they put on their bodies.”

During this new Chemical Watch global summit our expert speakers will discuss the latest developments in chemicals management and restrictions in cosmetics.

Hear the latest updates on key topics, including regional cosmetic frameworks, ingredient transparency and approaches to animal testing. You can also network virtually with other attendees, and put your questions to our expert speakers during the dedicated Q&A sessions.

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The US FDA has released a proposed order again soliciting information to evaluate the safety of some of the most commonly used sunscreen chemicals.

This is the latest step in over-the-counter (OTC) drug approval reform mandated by 2020’s Coronavirus Aid, Relief and Economic Security (CARES) Act, which temporarily deemed 16 currently sold active ingredients (AIs) ‘generally recognised as safe and effective’ (Grase).

If finalised as drafted, the 24 September proposal would confirm two substances’ Grase status, deny it for two more and potentially affect the other 12’s path to market.

The measure follows years of uncertainty regarding the market access of existing and unauthorised sunscreen compounds, as well as heightened inquiry into many of the chemicals’ health and environmental effects (see box).

Similar to a 2019 proposed rule, the order would designate only zinc oxide and titanium dioxide Grase, at levels up to 25%. Two other AIs – aminobenzoic acid (PABA) and trolamine salicylate – would not be Grase because their hazards outweigh their advantages, the FDA said, citing problems like dermal reactions and bleeding.

For the remaining 12 substances, the agency said: “The public record does not contain sufficient data to support a positive Grase determination.” These are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone and avobenzone.

The agency repeated its 2019 request for stakeholders to resolve knowledge gaps so it can assess these compounds’ Grase classifications “in light of changed conditions, including substantially increased sunscreen usage and

exposure and evolving information about the potential risks.”

According to the Personal Care Products Council (PCPC) and Consumer Healthcare Products Association (CHPA): “Sunscreens made with these ingredients are not considered unsafe and will remain on the market to be used as part of consumers’ sun-safe practices while more data are collected.”

Insect-repellent sunscreens are ‘not Grase’ under the proposal. For products created through nanotechnology, the FDA said it would not decide whether they were Grase based solely on nanomaterial use.

The agency will consult on the proposed order until 12 November, looking for details that have emerged since the earlier consultation, and factoring in material provided then.

Substances found to be ‘not Grase’ in the final order will not be able to stay on the

US FDA proposal repeats data call for sunscreen ingredient reviewAgency taking comments until 12 November to inform a dozen ‘Grase’ listings

28 September 2021

Americas

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market without new drug applications (NDAs).

Although the agency has no statutory deadline to finalise the order, Theresa Michele, director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, told Chemical Watch it cannot enter into force until at least one year after the proposal’s publication, or 24 September 2022.

Industry efforts

Ms Michele said if stakeholder submissions fail to answer the agency’s queries, but it has “received satisfactory indication of timely and diligent progress on necessary studies for particular ingredients”, it could delay their final

orders up to a year. And the agency could offer extensions “depending on further satisfactory progress”, she said.

But without adequate progress, Ms Michele added, “we will proceed to a revised final order” for each active ingredient.

According to Ethan Jorgensen-Earp, senior public affairs adviser for the Public Access to SunScreens (PASS) Coalition, research “has really focused on eight ingredients that represent the vast majority of the products on the market”. These are avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone, ensulizole and meradimate.

For these compounds, industry “has undertaken a number of activities to try

and move the ball forward, which will help FDA make its decision to afford them the time needed to complete the data requirements”.

Mr Jorgensen-Earp told Chemical Watch that the agency is likely to categorise the rest of the information-deficient substances as “not Grase”, with “no real impact on consumers”.

However, Scott Faber, senior vice president for government affairs at the Environmental Working Group (EWG), said: “Industry continues to bury its head in the sand” when it comes to AIs’ health consequences. Greater sunscreen sales mean “companies can certainly afford to conduct the studies needed to ensure their customers are safe”, he said.

The FDA is scrutinising the environmental implications of a pair of controversial sunscreen compounds – oxybenzone and octinoxate – recently banned by Hawaii, the US Virgin Islands, Palau and Thailand.

The agency stopped accepting relevant public feedback last week, and will produce an environmental impact statement (EIS) covering their effects on coral and other organisms before finalising the order.

However, the EIS will not influence the final order, Ms Michele said. Grase status is governed by the Food, Drug and Cosmetic (FD&C) Act’s “provisions related to safety and efficacy in humans”.

But Mr Jorgensen-Earp said the environmental analysis could “slow down the overall process of recategorising the ingredients” and supplement any potential ‘not Grase’ findings.

Meanwhile, the National Academy of Sciences (NAS) is investigating the aquatic interactions of AIs and possible public health consequences of shifts in sunscreen consumption.

Ecological concerns


The California Department of Public Health (CDPH) has updated the list of reportable ingredients under its safe cosmetics programme to include the substances designated in the Cosmetic Fragrance and Flavor Ingredient Right to Know Act (SB 312), which was signed into law last year.

From January, manufacturers of cosmetic products sold in the state

will have to disclose the use of flavour and fragrance ingredients, or fragrance allergens, that appear in any of more than 20 authoritative lists.

Along with the updated list, the public health department provided guidance and several ‘frequently asked questions’ (FAQs) to help companies comply with the coming requirements.

The department said it is also updating the portal used for reporting under the California Safe Cosmetics Act (CSCA) to enable fragrance and flavour ingredient reporting as well.

California updates list of reportable cosmetic ingredientsInformation website advises on reporting fragrance, flavour ingredients

23 September 2021

Did you know there are 43 active bills in the US related to personal care products?

RETAIL63

FIREFIGHTING43

TEXTILES ANDCLOTHING26

CLEANING PRODUCTS12

OTHER197

FOOD CONTACT59

MEDICAL DEVICES1CHILDREN'S PRODUCTSAND TOYS29

BUILT ENVIRONMENT47

ELECTRONICS12AUTOMOTIVE ANDAEROSPACE1

The information in this infographic was provided by Chemical Watch’s US legislation tracker tool. See more

*Between January and end-June 2021

https://home.chemicalwatch.com/us-state-legislation-infographic/


Mexico’s Senate has passed a bill that will impose a complete ban on cosmetics animal testing, making it the first country in North America and the 41st country globally to do so.

The bill passed unanimously on 2 September and will prohibit the manufacture, import and marketing of cosmetic products, or those that contain any ingredients or combinations of them, that have been tested on animals, according to a Senate statement presenting it. It will come into force upon its publication in the Mexican Official Journal.

The country’s Senate passed an earlier version of the bill in March last year, which then went to the lower house of Mexico’s legislature, the Chamber of Deputies, for consideration.

Lawmakers passed the bill in April, but made minor tweaks to the transitory articles, meaning it had to be sent back to the Senate for final approval.

The earlier bill outlined provisions for a one-year transition period for manufacturers to replace animal testing with “alternative methods to assess the safety and efficacy of cosmetic products”. The final bill extends this to two years.

Manufacturers and importers will need to indicate on the packaging that no animal testing has taken place. In addition, sanctions are stipulated for violating the ban, including fines and prison sentences of two to seven years.

Antón Aguilar, the executive director of NGO Humane Society International (HSI) in Mexico, called the ban a “monumental step forwards for animals, consumers and science in Mexico”, adding that it “leads the way for the Americas to become the next cruelty-free beauty market, and brings us one bunny-leap closer to a global ban”.

Cosmetics animal testing is currently banned in 40 countries, as well as ten states in Brazil and seven in the US.

Three other US states — New Jersey, Rhode Island and New York – are currently considering similar bills, and federal bills are pending reintroduction in both the US and Canada.

Mexico is the third country in Latin America to ban it after Guatemala and Colombia, which passed legislation to prohibit the practice in 2017 and 2020, respectively. Chile and Brazil are currently also working on legislation to do so, Mr Aguilar told Chemical Watch.

The EU has banned cosmetics animal testing since 2013. However, animal rights NGOs have recently launched an attack on Echa’s testing requirements, which they say threaten to undermine the ban.

Mexico passes complete ban on cosmetics animal testingManufacturers have two years to move to alternative methods

08 September 2021

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More than half of private-use tooth whitening products analysed in Denmark have been found to be potentially harmful to consumers due to high concentrations of hydrogen peroxide or a low pH value.

The country’s Environmental Protection Agency examined 25 products purchased from domestic, EU and non-EU distributors for the presence of three active substances used for whitening: hydrogen peroxide, sodium chlorite and hypochlorite.

The EPA also tested for boron because some products had boron-containing substances listed on the label even

though these are banned from use in such products under the EU cosmetic products Regulation.

In 15 products, discrepancies between substances declared on the label and analysis results, or deviations from the restrictions in the cosmetics Regulation, were detected, the EPA said in a report published yesterday.

For ten products, the pH value was below 5.5 and therefore posing a risk of damage to the tooth enamel. Two products had a pH value of 0 and 11.5, which constitutes a risk of corrosion effect on mucous membranes.

There are no general limits on pH values in cosmetic products.

Three products exceeded the legal threshold value of 0.1% content or release of hydrogen peroxide stated in the cosmetic products Regulation.

In 2012, Denmark introduced new rules on tooth whitening products containing hydrogen peroxide. Products with concentrations greater than 0.1% can only be sold to and used by dentists.

Danish tests reveal potential harm from private-use tooth whitening productsHigh levels of hydrogen peroxide or low pH detected in more than half of items tested

21 September 2021

Europe

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The European Parliament has adopted a resolution calling for an EU-wide action plan with “ambitious and achievable” objectives and timelines for phasing out the use of animals in research and testing.

On 15 September, 667 MEPs voted in favour with just four against. The resolution calls on the Commission to improve coordination to achieve the goal set out in the 2010 Directive on the protection of animals used for scientific purposes.

Efforts to act have increased, following a Commission report published last year that found that up to 12 million animals were bred and killed for the purpose of animal testing in 2017 without being used in actual experiments. According to NGOs this number has remained relatively unchanged in the last decade.

Because of this, MEPs voted in favour of the resolution, which suggests the Commission can be more effective in attaining the 2010 Directive goal by

“establishing a high-level inter-service taskforce”.

This should involve all key European Commission Directorates-General and agencies, working with member states and relevant stakeholders to draw up an EU-wide action plan.

The plan should set reduction goals in consultation with relevant agencies, in particular Echa and the European Food Safety Authority (Efsa), through a more “proactive implementation of the current regulations on the safety of chemicals and other products”.

Increased funding

In addition, the resolution highlights the need for increased and targeted funding, under the EU’s financing programme, Horizon Europe, to advance non-animal test methods.

“The Commission, the Council and the member states [should] make sufficient medium- to long-term funding

available to ensure the fast development, validation and introduction of alternative testing methods to replace animal testing methods, particularly for key toxicological endpoints,” it said.

Pressure has been mounting on the Commission to provide more funding to ensure animal testing is reduced under the chemicals strategy for sustainability.

This sets out a commitment to foster multidisciplinary research and digital innovations for advanced tools, methods and models, and data analysis capacities to move away from such testing.

To achieve this, the Commission said it plans to engage in the European Partnership for the Assessment of Risk from Chemicals (Parc), an EU-wide research and innovation programme between member states and the European Commission, to boost the transition to next-generation risk assessment for chemicals.

European Parliament adopts resolution calling for action plan to phase out animal testingMEPs want objectives, timelines and a high-level taskforce

16 September 2021

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It also said the average annual budget to fund alternatives to animal testing exceeds €45m.

However, in August, Dr Katy Taylor, director of science at NGO Cruelty Free Europe, said this is not enough, especially considering the likely increase in testing to meet the growing number of information requirements coming under the chemicals strategy.

In August, Cefic and Cruelty Free Europe also highlighted that the potential

“unreliability and lack of validity” of animal testing means hazard data for some endpoints gathered under REACH could be inconclusive.

The resolution urges that scientists, researchers and technicians must be trained in using advanced non-animal models and sharing best practices.

Animal welfare groups have welcomed the vote. Troy Seidle, NGO Humane Society International’s vice president for research and toxicology, said: “This vote

signals the need for systemic change in the EU’s approach to safety science and health research, with Parliament embracing an historic opportunity to take animal suffering out of the equation and shift the focus to modern, human relevant technologies.”

Cosmetics ban on animal testing

In August, animal protection groups and companies launched a European Citizens’ Initiative (ECI) in an attempt to put pressure on the European Commission to legislate a stricter ban on animal testing of cosmetic ingredients.

The petition comes in light of an ongoing and heated debate over whether requirements set out under REACH, which sometimes lead to cosmetics-only substances being tested on animals, undermine the marketing ban under the cosmetics Regulation.

Animal welfare campaigners say that such testing is incompatible with the cosmetics Regulation’s animal testing ban, which came into force for ingredients in 2009.

In related news, Mexico’s Senate passed a bill on 2 September that will impose a complete ban on cosmetics animal testing, making it the first country in North America and the 41st country globally to do so.


The Chinese National Medical Products Administration’s initial acceptance of a French GMP certificate as ‘receivable’ could indicate that France is close to being approved for the country’s 1 May waiver on pre-market animal testing on imported ‘general use’ cosmetics.

The NMPA will waive the requirement for mandatory toxicological tests where companies can supply official certification of their products’ manufacture, proving, for example, that they have met ISO or good manufacturing practice (GMP) safety standards.

However, companies will have difficulty meeting this requirement because few foreign authorities provide this.

Positive steps

A spokesperson for the French Federation for Beauty Companies

(Febea) told Chemical Watch that the NMPA considers a French GMP certificate to be ‘receivable’. The body can reject documentation immediately on receipt that does not fulfil its requirements.

Despite the NMPA not yet approving the application or giving any indication of when it might do so, the spokesperson said the acceptance of the certificate is a positive step towards China accepting non-animal tested general use cosmetic products.

The French Ministry of Health (MoH) and Febea discussed the Cosmetics Supervision and Administration Regulation (CSAR) prior to the final version being published in June 2020, and issued its own regulations relating to it that September.

One month on, at Febea’s request, France’s National Agency for Medicines

and Health Products Safety (ANSM) set up a dedicated platform to help companies acquire the necessary GMP certification. Piloted in October last year, it provides cosmetics companies with IT support and the processes and information they need for the documentation.

By 12 January – following the NMPA publishing the final Measures for filing and registering cosmetics – the ANSM was reviewing submissions for GMP certificates.

GMP platform

French cosmetics manufacturers can now use the platform to obtain the certification required for China’s animal testing waiver. Each request for a certificate via the platform will cost €1,400 (US$1,655), as decreed on 30 December 2020 under Section R. 5131-2 of the Public Health Code.

France edges closer to selling non-animal tested cosmetics in ChinaGMP certificate has been deemed to be ‘receivable’

16 September 2021

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“China does still require animal testing for special use cosmetics, with the main argument being [for] placing consumer safety first. Industry needs strong advocacy to explain/convince Chinese authorities that there are other suitable methods for proving safety, which is a challenge,” the Febea spokesperson said.

Febea confirmed that it is also aware of the NMPA accepting a New Jersey GMP certificate. It said increased sharing of animal testing waiver information is currently taking place between industry organisations, members and their Chinese manufacturers and suppliers. It has been contacted by several other countries about its establishing of the GMP certificate platform, it said.

Additional sub regulations for CSAR

On 6 August the NMPA published the Measure of Supervision and Administration for Cosmetic

Manufacturing and Operations as an additional regulation under the CSAR. It will enter into force on 1 January.

It covers various measures including clarifications on: • the procedure for obtaining and

maintaining a production licence;• companies’ requirements for

implementing a quality and safety management system;

• label requirements and additional information on addressing false claims;

• strengthening obligations for e-commerce platforms; and

• consumer obligations for businesses, such as hotels and beauty salons, using cosmetics.

Cosmetics in China

On 1 January, the Cosmetics Supervision and Administration Regulation (CSAR) replaced the Regulations Concerning the Supervision and Hygiene of Cosmetics. Subsequently, China’s National Medical Products Administration (NMPA) published subsidiary regulations on registration and filing – which entered into force on 1 May – that provide an animal test exemption for general use cosmetic ingredients and products.

Cosmetics in China are divided into general and special use, with the former accounting for the majority on the market. General use cosmetics are commonly used in hair, skin and nailcare products, perfumes and make-up.

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Australia’s Therapeutic Goods Administration (TGA) is looking into whether sunscreen products sold in the country contain excessive quantities of benzene, benzophenone and octocrylene. The investigation could be expanded to other substances of concern.

Product licences could be revoked or recalls issued for any sunscreens found to be in violation with limits laid out in the country’s sunscreen standard.

The investigation results will be published on the TGA website when available, with Australian sunscreen manufacturers and distributors being given the chance to respond in advance. No definitive timeframe for conducting the work has been set.

The move was prompted by US reports indicating some sunscreens contain

levels of benzene exceeding FDA permitted limits. This was reinforced by Healthcare giant Johnson & Johnson’s 2 August recall of all batches of Neutrogena Ultra Sheer Body Mist Sunscreen Spray SPF 50+ (aerosol sunscreen) – due to detecting benzene in some Australia-supplied products.

Benzene

TGA investigations are risk-based and triggered by indications of non-compliance with relevant standards or safety concerns (see box). Under Australia’s sunscreen standard the TGA allows a maximum benzene concentration of 2ppm, which is in line with the US FDA restrictions.

Benzene is used as a solvent in the chemical and pharmaceutical sectors and could appear in trace amounts in various products, including sunscreens.

The administration has already collected 20 samples of sunscreens and anticipates collecting at least another 20, a spokesperson from the TGA told Chemical Watch. It will focus primarily on aerosol sunscreens, because a report from US independent laboratory, Valisure, identified these products as having the highest level of the chemical.

The TGA spokesperson said its study could be extended to other substances of concern if information on their potential presence in sunscreens comes to light.

Benzophenone and octocrylene

It confirmed that it is conducting a separate investigation into products containing octocrylene, which is targeting the presence of benzophenone in a wide range of sunscreens.

Australia investigating substances of concern in sunscreensPrompted by US reports of products containing excessive quantities of restricted ingredients01 September 2021

Asia-Pacific

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Octocrylene is a common sunscreen ingredient that is used as an ultraviolet radiation absorber and stabiliser for the active ingredient, avobenzone. However, there are concerns that the substance can break down to form the carcinogen benzophenone.

It is approved as an active ingredient in sunscreens at a maximum concentration of 10% in Australia. The TGA does not currently consider it to present an

unacceptable safety risk when products are used as directed.

“The TGA is aware of reports in relation to benzophenone accumulation over time in sunscreen product formulations containing octocrylene, potentially due to octocrylene degradation,” the spokesperson said. “It has been reported to be detected only at trace amounts in octocrylene-containing products.”

The TGA is actively monitoring the available data about the carcinogenic potential of benzophenone. “There is currently insufficient information to conclude that sunscreens that are compliant with [the] existing requirements for product stability, and impurities such as benzophenone, are unsafe,” they added.

Sunscreens marketed in Australia

Sunscreens in Australia are only permitted to contain pre-approved, low-risk ingredients that have undergone toxicological and quality assessments in accordance with the Australian Regulatory Guidelines for Sunscreens.

They must also comply with the requirements specified in the Australian and New Zealand Sunscreen standard – AS/NZS 2604: 2012 – which includes sun protection factor (SPF) performance, water-resistance and labelling.

The TGA conducts post-market compliance on sunscreens included in the Australian Register of Therapeutic Goods (ARTG).

This includes laboratory tests and reviews of their quality, safety and efficacy to ensure they meet the legal requirements for ingredients that are permitted for use in sunscreens. • For non-compliance, the TGA can take a number of regulatory

actions, including:

• directing manufacturers and distributors to update product labels;

• removing the product from the ARTG so that it can no longer be lawfully supplied to consumers; and

• recalling the product from the domestic market.


Thailand’s Department of National Parks, Wildlife and Plant Conservation (DNP) has banned people from bringing and using sunscreen containing chemicals that are harmful to corals into the country’s marine national parks.

The ban applies to sunscreens that contain the following chemicals:• oxybenzone (benzophenone-3);• octinoxate (ethylhexyl

methoxycinnamate);• 4-methylbenzylidene camphor; and• butylparaben.

Announced on 24 June, the ban came into force on 3 August after being published in the government Gazette.

The DNP, which is an agency of the Ministry of Natural Resources and Environment, prohibited the substances under six of its own regulations and “under the powers of Section 20 of the National Park Act B.E. 2563 (2019), and Section 32 of the Public Administration Act B.E. 2534 (1991) and the

amendments No, 5 B.E. 2545 (2002)”, Dr Piyatida Pukclai, of consultancy knoell Thailand, told Chemical Watch

Visitors bringing sunscreens containing the banned substances to any of Thailand’s marine national parks are now subject to fines of up to 100,000 baht (US$3,000).

In justifying its action, the department said that many tourists visiting the parks use sunscreens with chemicals that contribute to the deterioration of coral reefs.

“Because these chemicals destroy coral larvae, it interferes with the [coral’s] reproductive system and causes coral bleaching,” the department said.

It added that the ban has been introduced “in order to preserve and conserve … protect and maintain natural resources and prevent damage to corals and ecosystems in national parks”.

Thailand bans sunscreens containing coral-harming chemicals from national parksAim is to protect and maintain natural resources and prevent damage to ecosystems

12 August 2021

Initiatives taken elsewhere

• The Republic of Palau, a West Pacific island nation, became the first country in the world to implement a ban on “reef-toxic sunscreens” in January 2020. In July 2019, the US Virgin Islands passed legislation to ban sunscreen products containing oxybenzone and octinoxate in stages from 31 December 2019. And the Florida city of Key West has also passed legislation to ban sunscreens containing these substances.

• Scientists in the US have recently asked the FDA to pull all sunscreens and personal care items containing octocrylene from the market because they say the substance can form the carcinogen benzophenone.

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On 1 January 2021, China’s new cosmetics framework – the Cosmetics Supervision and Administration Regulation (CSAR) – came into force, changing the definition of cosmetics and how they will be managed.

The framework defines cosmetics as: “Chemical products in daily use that are applied on the surfaces of the human body such as skin, hair, nails, and lips

by way of rubbing, spraying, or other similar methods for the purposes of cleanliness, protection, beautification, and improvement.”

It excludes the “elimination of unpleasant odour” from the definition. Hair growth, depilating, breast beauty, slimming and deodorant, which used to be managed as special use cosmetics, have been

reclassified as general use cosmetics under the new framework.

Reclassification of products under CSAR

Under CSAR, cosmetics now are classified, based on their level of risk, as either:• special use cosmetics; or• general use cosmetics.

Special use cosmetics are those with high risk functions, including antiseptic, sunscreen, colouring, hair dyeing, anti-freckle and whitening. Product types include cosmetics used for: • hair dyeing; • hair perming; • anti-freckle and whitening; • UV protection (sunscreen);• hair loss prevention; and

• cosmetics that claim new efficacies not classified under technical guidelines published 9 April: Rules for the Classification and Classification Catalogue for Cosmetics.

Expert Focus: What does China’s new cosmetic regulatory framework mean for business?This article is an abbreviated excerpt from an Expert Focus article that covers CSAR classification and requirements for registrations, notifications and labelling.

25 August 2021

Excerpt

©adobe.stock.com


General use cosmetics include all cosmetics that are not classified as special use.

All new cosmetics manufactured/imported after 1 January 2021 must comply with CSAR. However, cosmetic products for hair growth, depilating, breast beauty, slimming and deodorising that were previously managed and registered as special use cosmetics before 1 January 2021, can continue to be manufactured, imported and sold in China under their existing registration during a five-year transition period.

Soaps continue to be out of scope. However, they would still be required to obtain a registration certificate if they contain a special use efficacy claim, for example for whitening. Toothpaste is deemed a general use cosmetic and requires notification before distribution/use.

Soaps continue to be out of scope. However, they would still be required to obtain a registration certificate if they contain a special use efficacy claim, for example for whitening

Special use cosmetics must be registered in accordance with the new requirements under CSAR. The registered cosmetic certification is valid for five years. General use cosmetics and ingredients must be notified via the National Medical Products Administration (NMPA) new integrated website.

Dossier requirements

New cosmetics registration or notification

The following information must be submitted when applying for registration or notifying a cosmetics product:• a cosmetics registration and

notification information form, and related documents;

• basis of product name;• product formula;• product executive standard;• a draft sample label;• a product inspection report; and• any product safety assessment

documents.

Except for products manufactured exclusively for the Chinese market, imported cosmetics must be accompanied with a sales certificate issued by a competent government department (or industry association) of the exporting country, or country (or region) where the cosmetics registrant or notifier is located. The sales certificate must contain, as a minimum: • the name of the registrant, filing person

or manufacturer;• the name of the product;• the name of the institution that issued

the document; • the date of issuance of the document;

and • the institution’s signature and seal.

If both imported and domestic components are combined in the final product, only the sales certification documents of the imported part must be submitted. If the product is sold in another country but the package has been re-designed exclusively for the Chinese market, the registrant or filer must submit:• the sales certificate for the product

issued where the cosmetics registrant

or the filer is located, or where the product is produced (region);

• product formulation;• a document explaining the

manufacturing process.

Cosmetics registrants and notifiers can no longer make claims without substantiating them with scientific evidence

If a product formulation is designed exclusively for the Chinese market (except for domestically commissioned overseas production), the registrant or filer must submit:• documents explaining the formulation

designed according to Chinese consumers’ skin types, needs etc; and

• documents explaining the selection of Chinese consumers to conduct consumer test research or human efficacy test data.What do the changes mean for cosmetics companies?

Although the new regulatory framework is designed to reduce the administrative burden on industry and align with international standards, the requirements still present many challenges for companies.

Animal testing exempted for general use cosmetics

Dossiers for general use cosmetics are no longer required to include animal test data, regardless of whether they are produced domestically or imported into China. When filing, companies may now opt to submit overall product formula safety analysis such as safety assessments equivalent to the certificate of compliance to good manufacturing


practice (GMP) and toxicological test reports – or apply for exemption from submitting toxicological tests.

More onus on companies to prove the safety of ingredients, products and efficacy claims

Under CSAR, companies are required to take full responsibility for ensuring the safety and efficacy claims of their products. From 1 January 2023, all cosmetic ingredients must be substantiated with safety-related information when registering or submitting a notification.

Increased administrative requirements – signatures/seals

With the exception of original documents issued by government authorities or relevant agencies – including inspection

and testing institutions, notary agencies – registration and filing materials must have every page stamped by a domestic registrant, filing party or domestic responsible person.

Conclusion

Compared with the old regime, the new cosmetic regulatory framework provides companies with much greater clarity with regards to the requirements of cosmetics and new cosmetic ingredients management. It also enhances the overall quality and safety of cosmetics in China. Cosmetic manufacturers/importers are now directly held accountable for the quality and safety of their products. Consumers are better protected from unsafe; untested products or misrepresentations by companies.

However, this has also brought increased challenges to cosmetic companies, in terms of the additional costs and time required to launch their products. Careful planning and pre-market regulatory and compliance analysis is key to mitigating those challenges.

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