During the period from January to March 2024, several noteworthy regulatory developments have taken place globally. Notably, the Chinese mainland plans to introduce a transition period for safety assessment and makes amendments to Safety and Technical Standards for Cosmetics. Moreover, countries/regions including South Korea, Japan, Malaysia, Vietnam, the EU, the US, and New Zealand have also implemented some regulatory changes. Here are brief updates on these developments.

1. EU

EU Amends the Use Requirements for 13 Nanomaterials in Cosmetics

On May 23, 2023, the European Union (EU) notified WTO of a draft Commission Regulation proposing revisions to the ingredient lists in Regulation (EC) No 1223/2009 concerning the use of nanomaterials in cosmetics. On March 15, 2024, the EU published the finalized regulation in the Official Journal, and it came into effect on April 4, 2024. The regulation includes the following amendments:

1. Ban on 12 nanomaterials: Due to insufficient safety data and concerns regarding potential health risks to consumers, the EU has prohibited the use of 12 specific nanomaterials in cosmetics;
2. Restriction on Hydroxyapatite (nano): The Scientific Committee on Consumer Safety (SCCS) assessed Hydroxyapatite (nano) and determined that it can be safely used in cosmetics under certain restrictions. Consequently, it is added to the list of restricted ingredients.

Starting from February 1, 2025, cosmetic products containing the 12 banned nanomaterials, or containing Hydroxyapatite (nano) that do not comply with the restrictions may not be placed on the EU market. From November 1, 2025, these products may not be made available on the EU market.

New Update to Candidate List of SVHCs

On January 23, 2024, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs, expanding the list by five substances and bringing the total number of SVHCs to 240. The newly added substances are:

• 2,4,6-tri-tert-butylphenol (2,4,6-TTBP)
• 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol (UV-329)
• 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one
• Bumetrizole (UV-326)
• Oligomerization and alkylation reaction products of 2-phenylpropene and phenol (OAPP)

Additionally, the entry for DBP was updated to include its endocrine disrupting properties for the environment.

In March 2024, ECHA initiated a consultation to identify two substances proposed by Norway and France as SVHCs. The public can provide comments on these proposals until April 15, 2024. Once identified as SVHCs, both substances will be added to the Candidate List. The two substances under consideration are:

• Bis(α,α-dimethylbenzyl) peroxide
• Triphenyl phosphate

ECHA Consults on Recommending Five Substances for Authorization List

On February 7, 2024, European Chemicals Agency (ECHA) released a draft 12th recommendation to the European Commission, which recommends the inclusion of 5 substances to the REACH Authorisation List.

1. Melamine
2. Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof
3. S-(tricyclo[5.2.1.0 2,6]deca-3- en-8(or 9)-yl) O-(isopropyl or isobutyl or 2-ethylhexyl) O- (isopropyl or isobutyl or 2- ethylhexyl) phosphorodithioate
4. Diphenyl(2,4,6- trimethylbenzoyl)phosphine oxide
5. Barium diboron tetraoxide

ECHA is looking for further information on the uses of these substances in scope of authorization, their possible exemptions from the authorisation requirement and on the structure and complexity of the supply chains. The consultations are open until May 7, 2024.

ECHA Announces Next Steps for PFAS Restriction Proposal

In March 2024, the European Chemicals Agency (ECHA) delineated a schedule for evaluating the PFAS restriction proposal, with attention given to various sectors, including cosmetics. This evaluation will have implications for manufacturers globally, who will need to make adjustments to align with the new standards.

2. US

MoCRA Updates: FDA Unveils Additional Submission Tools for Cosmetic Facility Registration and Product Listing

On January 8, 2024, the U.S. Food and Drug Administration (FDA) introduced new submission tools to supplement the existing electronic submission portal, Cosmetic Direct. These tools include Structured Product Labeling (SPL) Xforms, as well as Form FDA 5066 and Form FDA 5067. These additions offer stakeholders increased flexibility in meeting their specific needs in cosmetic facility registration and product listing.

1. Structured Product Labeling (SPL) Xforms: This tool serves as an SPL authoring tool, facilitating the creation of SPL file containing information on cosmetic product facility registration and product listing;
2. Form FDA 5066 and Form FDA 5067: These forms are designated for paper submissions. Form FDA 5066 is used for cosmetic facility registration, while Form FDA 5067 directs at cosmetic product listing.

3. China

NMPA Plans to Set a Transition Period for Submission of the Full Version of Safety Assessment Report

Until May 1, 2024, China National Medical Products Administration (NMPA) allows a simplified version of cosmetic safety assessment report for registration or notification. However, starting from May 1, 2024, the full version of the report is required. This transition poses challenges for the industry due to difficulties such as lack of ingredient toxicological data and shortage of safety assessment personnel.

To optimize safety assessment management, NMPA is formulating measures in four aspects:

1. Setting a six-month transition period. Registrants and notifiers who have already started safety assessments before May 1, 2024, will be permitted to submit a simplified report within a specified timeframe;
2. Strengthening technical guidance by introducing draft guidelines for Threshold of Toxicological Concern (TTC) Method and Read Across, and formulating guidelines for physical and chemical stability, preservative challenges, and packaging material compatibility testing;
3. Integrating ingredient data resources by establishing a cosmetic ingredient safety database;
4. Innovating assessment report management mechanisms by categorizing cosmetics into three tiers based on risk levels. Category 1 cosmetics require complete safety assessment reports, while Category 2 and Category 3 cosmetics only need safety assessment conclusions.

ChemLinked Comments

The above measures are still in draft form and yet to be implemented. Companies are advised to proactively prepare for the full version of the report. This includes assembling qualified personnel, reviewing ingredients and addressing data gaps, and seeking expert consultants, etc.

NMPA Amends the Safety and Technical Standards for Cosmetics 2015

On March 21, 2024, NMPA announced significant amendments to the Safety and Technical Standards for Cosmetics (2015 Edition) (STSC). The updates include:

1. Addition of 5 newly prohibited ingredients: Bimatoprost, Tafluprost, Taflupamide, Travoprost, and Latanoprost;
2. Revision of 3 existing testing methods, including those for dioxane and other prohibited and restricted ingredients;
3. Introduction of 11 new testing methods, covering areas such as acute inhalation toxicity, skin sensitization, and reproductive toxicity.

The updated ingredient list is in effect immediately, while the revised testing methods will take effect on December 1, 2024.

4. Taiwan

TFDA Amends Cosmetic Ingredient Use Requirements

Taiwan Food and Drug Administration (TFDA) issued several announcements on December 13, 2023, and January 4, 2024, regarding the revision of prohibited and restricted ingredients for cosmetics. Please refer to the table below for the specific amendments.

5. South Korea

South Korea Bans THB in Cosmetics

On December 7, 2023, the Ministry of Food and Drug Safety (MFDS) proposed an amendment to the Regulation on Safety Standards for Cosmetics. The purpose was to prohibit the use of 1,2,4-trihydroxy benzene (THB) as an ingredient in cosmetics. The decision was based on safety verification results from the Cosmetic Ingredient Safety Evaluation Committee, which indicated that the genotoxicity potential of THB cannot be ruled out.

The amendment was finalized on February 7, 2024, and MFDS officially implemented the ban on THB in cosmetics.

6. Japan

Japan Plans to Approve a New Ingredient for Rinse-off Hair Styling Products

The Ministry of Health, Labour and Welfare (MHLW) of Japan introduced a proposal for the Standards for Cosmetics on March 8, 2024. The proposal seeks to include “Cysteamine Hydrochloride” as an ingredient in hair styling products exclusively intended for hair application and rinsing off.

ChemLinked Comments

The revised standards are anticipated to be implemented in late June 2024. Cosmetic manufacturers and distributors will be required to adhere to the updated guidelines, which may involve modifying product formulations, manufacturing processes, labeling, and quality control measures.

7. Malaysia

Malaysia Amends Cosmetic Ingredient Use Requirements

On January 19, 2024, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released Circular No. 1/2024 Information on the Updated Status of Ingredients in the Annex of the Guidelines for Control of Cosmetic Products in Malaysia. According to the Circular, the amendments are:

1. Adding 15 ingredients to, and revising 4 ingredients in the List of Prohibited Ingredients;
2. Revising 5 ingredients in the List of Restricted Ingredients;
3. Revising 1 ingredient, CI 45430 (2), in the List of Permitted Colorants;
4. Deleting 1 ingredient, Methenamine 3-chloroallylochloride, from the List of Permitted Preservatives;
5. Adding 2 ingredients to, and revising 1 ingredient in the List of Permitted UV Filters.

ChemLinked Comments

Most of the aforementioned revisions align with the updates made to the ingredient annexes of the ASEAN Cosmetic Directive (ACD) during the 38^th ASEAN Cosmetic Scientific Body (ACSB) meeting. It is crucial for enterprises to stay informed about the updated ingredient usage requirements and refrain from incorporating newly prohibited ingredients into their cosmetic production processes. In cases where newly added or revised restricted ingredients are used, enterprises are recommended to ensure compliance with their updated usage conditions.

8. Vietnam

Vietnam Amends Cosmetic Ingredient Use Requirements

Drug Administration of Vietnam (DAV) released Official Letter No. 589/QLD-MP on March 4, 2024, to announce the updated use requirements for cosmetic ingredients. The amendments are:

1. Adding 15 ingredients to, and revising 4 ingredients in Annex II List of Substances Which Must Not Form Part of the Composition of Cosmetic;
2. Revising 5 ingredients in the Annex III List of Substances Which Cosmetic Products Must not Contain Except Subject to Restrictions and Conditions Laid Down;
3. Revising 1 ingredient, CI 45430 (2), in the Annex IV List of Colouring Agents Allowed for Use in Cosmetic Products;
4. Deleting 1 ingredient, Methenamine 3-chloroallylochloride, from the Annex VI List of Preservatives Which Cosmetic Products May Contain;
5. Adding 2 ingredients to, and revising 1 ingredient in the Annex VII List of Permitted UV Filters Which Cosmetic Products May Contain.

ChemLinked Comments

The above changes align with the updates to ACD passed by the 38^th ACSB meeting. Cosmetic companies are advised to proactively review cosmetic ingredients during production, import, and trade, in order to mitigate the risk of product recalls.

9. New Zealand

New Zealand EPA Bans PFAS in Cosmetics

On January 30, 2024, the New Zealand Environmental Protection Authority (EPA) announced a ban on PFAS in cosmetics. The ban, outlined in the updated “Cosmetic Products Group Standard,” reflects New Zealand’s precautionary approach to managing the potential risks associated with these chemicals.

To ensure compliance, the ban on PFAS in cosmetics includes the following transitional provisions:

1. Manufacture Ban: Starting from December 31, 2026, the manufacture and import of cosmetic products containing PFAS will be prohibited;
2. Sale Ban: As of December 31, 2027, the sale of cosmetic products containing PFAS will be banned;
3. Product Disposal: All remaining cosmetic products containing PFAS must be disposed of by June 30, 2028. This ensures the complete removal of these products from the market and minimizes potential PFAS exposure.

Conclusion

In conclusion, recent global regulatory updates demonstrate ongoing efforts to enhance and refine the cosmetics regulatory framework. China, in particular, is exploring ways to optimize safety assessment management. It is crucial for enterprises to stay updated on these management measures.

Furthermore, updates related to ingredients, especially the prohibition of certain substances, remain a significant area of focus in multiple countries globally. Stakeholders are advised to closely monitor these updates, adjust their strategies to comply with regulatory requirements, and ensure the quality and safety of cosmetic products in the market.

Further Reading

• China May Provide Six-month Transition Period for Submission of Cosmetic Safety Assessment Report (Full Version)
• EU Amends the Use Requirements for 13 Nanomaterials in Cosmetics
• MoCRA Updates: FDA Unveils Additional Submission Tools for Cosmetic Facility Registration and Product Listing
• New Zealand EPA Bans PFAS in Cosmetics

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Feeling inspired to see ingredients and trends in action?

Then why not visit one of the in-cosmetics events around the world?

BROWSE SHOWS

Open to both cosmetic manufacturers and suppliers of cosmetic ingredients, our Pre-Show Regulatory Conference offers expert insights and solutions surrounding compliance on an international scale.

Over the course of the workshop, participants will get a thorough assessment of the world’s biggest markets including EU, Latin America, the Middle East, Asia Pacific and North America.

We will look at each region’s regulatory modules to help you action the development and launch of your brand new personal care product. Covering the EU’s stance on micro-plastics right through to industry growth analyses, our contributors will discuss the regulations you need to know about across the industry’s essential markets.

Hear from the likes of COSMED, the Personal Care Products Council, Intertek and more about how to achieve product compliance across the major global markets in this interactive session.

Get your questions answered at the Pre-Show Conference. Taking place at in-cosmetics Global on 05 October 2020 from 13:30 – 18:30 in Workshop Room 1.

Reserve your place at the Pre-Show Regulatory Conference. Want to tackle one market at a time? Start by trying to understand EU Cosmetics Regulations.

Personal care businesses worldwide have been operating entirely online in the wake of Covid-19. Take a moment to ensure you are practicing compliance by reviewing these important digital regulations specific to each major global cosmetics market.

China

Trade in China must follow general trading standards, in addition to those outlined in the country’s specific Cross Border E-commerce (CBEC) policy. CBEC in China allows products like cosmetics to be purchased from international brands online. Products sold via CBEC are categorised as personal goods and are therefore exempt from regulatory requirements. Additionally, cosmetics sold via CBEC are able to avoid animal testing.

USA

USA Cosmetic products are regulated by the Food and Drug Administration (FDA), and the Fair Packaging and Labelling Act (FPLA).  Selling cosmetics online in the USA requires the same regulatory compliance as it does in-store. Another important consideration is state-specific regulations, a key localised example being the California Proposition 65 act.

European Union

Cosmetics sold in the EU market must fulfil standards laid out in the EU Cosmetics Regulation. Whether the sale is online or in-store, the governing body remains the same. Every product sold in the European Union will require an EU-based ‘Responsible Person’ (RP) with a product information file (PIF) set for review. The latter should document all details about the finished product, from its ingredient selection to the manufacturing process and product labelling.

Be aware that products sold online in the EU must have compliant labelling which should be reported to the Cosmetic Product Notification Portal (CPNP) before going on sale within the EU. Please note, these guidelines also apply to the UK market at the time of publishing.

Want to know more about the latest regulations? Sign up for our Pre-Show Regulatory Conference, taking place at in-cosmetics Global on 05 October 2020 from 13:30 – 18:30.

Theresa Callaghan PhD,  CEO Callaghan Consulting International, Hamburg, Germany

Cosmetics have much to look forward to in this new decade, yet at the same time our industry needs to reflect on where it sees itself in such a demanding consumer world, full of confusion and ‘fairy stories’. As we find ourselves nearing the middle of the first year of the ‘20s, will they be ‘roaring’ in the same way as the ‘20s of the 20th century? As a claims development specialist and skin scientist, it is clear the consumer will continue to drive for ‘truth’ from marketing, from ‘speed demons’ (non-compliant brands), and from risk takers when it comes to the claims narrative. To be honest, all consumers, which includes us, are pushing for further transparency right across the board  — our work cut out for us!

If we, as an industry, are to counter consumer ‘toxicologists’ and consumer ‘skin experts’ surrounding our products, well-thought out pro-activeness as a collective rather than as an industry full of competitors, is the key route for success. Analogous to beaches covered in plastic waste, industry fragmentation became so severe during the 2010s, that it gave birth to a tsunami of misinformation, and ‘drowned-out’ common sense. We owe it to ourselves and the continued betterment and evolution of the industry, to put the consumer, press, and social media, straight, once and for all. ‘Sense-about-science’ needs to be a champion for 2020 and the decade ahead. As an industry we focus on the average consumer, yet those consumers who are not-so-average are making a noise. Perhaps it is time to address them too in order to avoid the continued growth of the ‘pseudo-toxicologist’ and similar ‘experts’? With most consumers obtaining their cosmetic product information from ‘questionable’ sources, it is important that they are able to discern between fact and fiction so as to obtain a better grasp of the products they need for healthy, beautiful skin. They should also be more informed when choosing and purchasing cosmetic products, and be more informed when judging what they read in the press and on the internet and social media. Despite what some people think, advertising can’t make you buy something you don’t need!

Communicating facts is always a challenge for experts whatever the industry or field of research they occupy. The average consumer is more than happy to trust climate and environmental scientists, with some of them being considered cool and hip despite their age. So where are our scientists? We have excellent credible researchers and experts, so why do we only hear from them (mostly) in B2B communications, rather than being ‘out there’ with the public? Serious beauty journalists are excited to speak to scientists — not PR managers or ‘spokespersons’ — they want the facts not the ‘pretty bits’ (which are a given). Another point to consider is that as an industry, despite our ‘family atmosphere’ we are in fact competitors, and so perhaps there is a reluctance for scientists to speak out since it goes against their company ‘politics’ and as we know, ‘image’ in our industry, rightly or wrongly, is everything?

Whether we are on board or resisting the challenge, product trends for 2020 will continue to centre around Sustainability — not necessarily through natural and organic products — despite anticipated growth, but also in terms of ethics, resources, people, and obvious overt consumerism. Will we see a reduction in consumption or in consumer waste? Whatever the marketing ‘trend’ sustainability will encompass all aspects of cosmetics. With a focus on sustainability the numbers of new ingredients is likely to be less, but with an increase in research and development into what we already have on offer. This will be impacted by the claims legislation. Furthermore, consumers may well search for products with locally produced ingredients, and demand transparency in terms of, e.g., ‘how many tons of CO2 produced this lipstick,’ written on the packaging. All of these claims will require legislative compliance. I am also of the belief that consumers will move away from products feeding their vanity and focus on their individual real skin needs in order to cut down on waste. The fashion industry is moving in this direction driven by the consumer — we will not be immune.

In terms of ethical trends, those who own an effective but honest and truthful narrative, when it comes to product claims (i.e., fully complaint), will be the winners. In claims development, whatever the trends of 2020, if the industry cannot be in control of the narrative in a transparent and informative honest manner, we may come to the point where regulatory control will no longer be in our hands. Either it will be in the hands of law makers, or it will be in the hands of consumers and their social media accounts. The latter doesn’t bear thinking about!

Communicating with consumers is, indeed, a challenge, and will continue to be so unless we can we crack the social media narrative. Why do we have these problems with communication? The biggest problem humans today have with communication is that we do not listen (or even read) to understand . We listen/read to reply! Too much emphasis is placed on ‘perceiving’ what is read, rather than reading to ‘weigh and consider.’ We need to make up our own minds individually, rather than as a ‘collective’. If we consider this issue in the context of cosmetic advertising it highlights the need for the cosmetic industry to ensure that claim messages and stories attached to their products are fully understood and not misconstrued in any way. At the same time, a course of effective proactivity and dialogue with consumers, journalists, and social media should be found to ensure the integrity of products is not lost or demeaned either deliberately or inadvertently. When the cosmetics industry communicates with the consumer, the communication at times arrives via a tangled web, and then the industry also has to assume the consumer reads what it is communicating. The benefit of effective communication is that it creates a good image, and as such, can build long-lasting relationships with consumers — and thus, brand loyalty

Development teams (and to be honest, not just in the cosmetics industry), have also found that while R&D transform the science (facts) into reality (e.g., can smooth out wrinkles), it is marketing which turns facts into dreams — focusing on for example, the insecurity that somehow wrinkles are not nice, and therefore, should be smoothed out. Thus feeding off a consumers pre-existing insecurity that they are becoming old. Moreover, by providing products to smooth out wrinkles (despite consumer desire for them), have they now identified the point where this insecurity becomes vanity and thus drives sales, or was the vanity of the consumer there in the first place but only exhibited as insecurity? Should marketing transform these facts from R&D to address a real consumer need? How vain are we as consumers?

Since 2013 we have consistently failed to effectively control the consumers narrative, especially when it comes to correcting ‘fake’ news. In my view, this is primarily due to those brands who will not, or do not comply with cosmetic claims legislation, guilty of terminological inexactitudes — basically lying about their products. Also, those brands who themselves make up negative stories about ingredients due to ignorance, lack of proper consumer insight, and failure (out of fear?) to challenge the consumer with correct facts. They then perpetuate these ‘stories’, because that’s what the industry is good at — ‘me-too’ claims were a disaster waiting to happen and now we have to clean up the mess. They fail to understand that non-compliance with just one out of six EU Claims Criteria means they are non-compliant with all of them since they are inextricably linked. This lays waste any so-called ‘ethical’ claim they may have, for example, attached to their product. Like speeding cars on a motorway, they think that because everyone else is doing it, they can do so themselves, and they hide amongst those around them — especially in the internet jungle. With only so many police to control them, it will be either the consumer or industry insiders waiting at the motorway exit with the speedometer. My advice is to drive safely in 2020, and avoid forest fires!

As consumers ourselves, our industry’s responsibility is therefore a big one in relation to effectively communicating truthful, believable cosmetic claims. We need to be ahead of the curve and ensure journalists, bloggers, amateurs, influencers etc, keep to the facts, fact check their sources, and prevent misinterpretation of those facts. Finally, we need some collective creative disruption when it comes to communication!

Note: Some of this article is adapted from excerpts of Dr. Theresa Callaghan’s book “Help! I’m Covered In Adjectives: Cosmetics Claims & The Consumer” available from Amazon (paperback and e-formats), and from SOFW (booth A56). Theresa also gives the annual Claims Development Workshop for In Cosmetics which is now in its 6th year.

Roziani Zulkifli, Exhibition Director for in-cosmetics Global
Sustainability, preservation challenges and the nuances of developing cosmetic claims, are just a few of the scientific and regulatory hurdles changing the face of today’s personal care industry. Evolving in line with consumer demands, as well as technological advancements, these market trends present new opportunities for the cosmetic and personal care community.

Helping the industry navigate the most pertinent issues facing the industry, leading scientific, technical and regulatory experts will come together at in-cosmetics Global to help identify and plan for future opportunities while offering insights into practical tools to enable them to navigate the future, optimise output and drive business forward.

Preservation challenges
An estimated 50% of the substances listed on Annex V of the European Regulation EC/1223/200g have been affected by increasingly tough regulations and consumer perceptions. This has brought the preservation of cosmetic products to the forefront of formulators minds.

The implications for the industry have proven to be both positive and potentially damaging. Being prompted to systematically review the toxicological properties of chemicals with the aim of increasing consumer safety, is no doubt a positive result.

On the other hand, pressure from both consumers and media for products that are perceived as less ‘synthetic’ has seen many chemicals that have been used for decades being phased out. This has had implications for formulators given the legal and ethical obligations to adequately preserve products in the safest way.

A thorough understanding of different technical approaches in terms of formulation, dermatology and toxicology will be the focus of the ‘preservation challenges & skin sensitivities’ workshop, on 30 March, when Dr. Andrea Mitarotonda PhD FRSC will explore the risk of increasingly challenging preservation practices.

Beyond the adjective of claims
We’re also returning to one of the most popular workshop topics, ‘beyond the adjectives of claims’, to explore the complexities and nuances of developing cosmetic claims. There are both challenges and opportunities to be found from the impact that scientific marketing and global consumer concerns surrounding sustainability can have on this process.

On 31 March, Dr. Theresa Callaghan PhD, a skincare scientist and cosmetic product claim specialist, will explain the importance of using the July 2019 EU support criteria as a foundation for any cosmetic product. By also analysing existing product labels, she’ll provide a basis through which to navigate current and emerging product trends and the process of making claims in a world increasingly focused on sustainability.

Skin microbiome: novel discoveries on healthy skin, testing methods and regulations aspects
The technological developments in genome sequencing and its more widespread application within the skincare market over the past two decades have created an opportunity for formulators and brand owners to create personalised products linked to skin microbiome. For brands looking to tap into this sector, it’s key to understand the different research tools available which allow formulators to operate with different levels of accuracy. On 31 March, we’ll provide access to experts including  Dr. Nava Dayan to discuss recent findings in skin microbiome mapping, research and regulatory aspects.

Formulating for a sustainable future – beyond natural & organic
One of the most prevalent topics across all industries right now is sustainability. Sales of certified organic and natural beauty products are higher than they’ve ever been, experiencing a 14% growth in sales in 2018.[1] Brands are recognising that products formulated with natural ingredients are warranting a higher annual market growth than synthetic products.

The opportunities and challenges for formulators continue to shift as the range of green raw materials that can be used in certified personal care products fluctuates. We know that one of the main challenges comes when assessing the sustainability profile of ingredients and the chemical processes that are permitted. By joining us in Barcelona on 1 April, attendees – including indie brands – will be provided with guidance on how to develop effective “green” formulations and navigate key marketing techniques and messaging to define sustainability credentials, led by Judi Beerling MBA, C.Chem. MRSC, Technical Research Manager, Ecovia Intelligence.

New avenues in haircare: hair exposome, latest research & technological advances
Another growing trend is the convergence of science and technology within the haircare sector. Four key drivers are said to be defining the market including Hair Exposome (HE) which defines a set of external and internal factors that provoke a human body response in hair health. Another key driver is scalp microbiome where microbe communications play an important role in scalp and skin health. Hair and colour regulations, understanding the mechanisms regulating pigmentation, along with the rising availability of cutting-edge technologies for hair research and analysis will also be explored in a dedicated hour-hour workshop, co-organised by Beauty Cluster Barcelona.

To gain a comprehensive understanding of the industry’s most significant challenges and opportunities, and to find out more about the in-cosmetics Global, paid-for programme of scientific regulatory workshops, visit https://www.in-cosmetics.com/en/education2020/workshops/

[1] Soil Association, Organic Beauty and Wellbeing 2019 Market Report 2019

Choosing which preservative to use is one of the hardest ingredient selections a cosmetic formulator needs to make. Why?

Not only is correct preservative one of the essential components of creating a product with a good shelf life, they are the subject of much scrutiny by consumers questioning their safety and necessity. So, here are some preservative myths – busted! And some great facts that will help guide your selection in the future.

Why are preservatives needed in personal care anyway?

Preservatives are needed in just about every personal care formulation containing water. Bacteria, yeast and mould are incredibly opportunistic organisms that given just enough favourable conditions, will grow and multiply rapidly. The ideal growth conditions for most bacteria, yeast and mould are temperate climate, source of water, nutrients and a pH anywhere from 3 to 10. Personal care commonly contains water, nutrients, stored at room temperature with a pH around 5 – 6. This means, most personal care products are an ideal food source for these micro-organisms to grow. The only thing that stops them: suitable preservative selection! So let’s take a look at some of those myths…

Myth #1: Some essential oils/extracts act as preservatives

While it is true that some essential oils and extracts can control or prevent some micro-organisms from growing, their mode of action is very selective – which means even when they are effective against some micro-organisms, their action is not broad enough to provide effective coverage of the huge array of micro-organisms that a personal care product may be exposed to over its shelf life, and consumer (ab)use. So, if we relied on the few essential oils/extracts that do have some anti-microbial activity, we’d be leaving a formula unprotected from many hundreds, possibly thousands, of micro-organisms that would still readily contaminate it. This means, a broad-spectrum preservative is still needed to ensure adequate protection.

The same applies to anti-microbial drug agents: they may be effective against very specific bacteria or fungi, but are not sufficiently broad spectrum to provide effective coverage of a cosmetic product to ensure safe use by a consumer.

Myth #2: My product has a pH of 3.5 so it’s mostly protected, and it’s too low for bacteria to grow anyway.

Mostly protected is not totally protected. You need to remember that micro-organisms are extremely opportunistic, so they’ll try to survive in even very adverse conditions. While ‘ideal’ growth conditions for most bacteria is a pH around 6 – 8; and for fungi (yeast and mould) pH 5 – 6, bacteria can still grow in more acid conditions just as fungi can grow in more alkaline conditions. That hair conditioner with a pH of 4-4.5 still needs broad spectrum preservation. That non-oxidative hair dyes have a pH of 9 – 9.5, still needs broad spectrum preservation. In other words, EVERY personal care product containing sufficient water to sustain growth needs a preservative where it has a pH greater than 3 or less than 10.

Myth #3: One broad spectrum preservative is all we need.

Just why are there so many preservatives anyway? The truth is, there is no ‘1’ preservative that is perfect in every formula, especially when you add in consumer selection criteria!

• • Some preservatives are only effective where the pH is less than 5.5.
  • Others may only be suitable up to a pH of 7. If these conditions don’t suit the final pH of my formula, then they may as well not be present!
  • Some INCI names contain the words ‘acid’ or ‘alcohol’ – and that can be off putting to some consumer groups.
  • Some preservatives are based on parabens – proven to be safe when used within limits but if a consumer is concerned about, you’ll have little chance of convincing them otherwise!
  • Others contain propylene glycol as a solvent that some consumers want to avoid.
  • Some aren’t compatible in anionic environments; some aren’t compatible with high contents of non-ionic surfactants.
  • Some contain formaldehyde releasers, also the subject of bad publicity.
  • Some have aromas that may not be compatible with the target market or other fragrances you want to use.
  • Some preservatives have a ‘static’ action to stop growth but can’t kill micro-organisms already present.
  • Some cause products to lose viscosity, or cause a pH to drop too much for the formulation created.

• Under EU Cosmetic Regulation, only preservatives listed in Annex V can be used in cosmetic products, within the limits stated. Some companies marketing preservatives have taken liberties to extend this ruling to infer that substances that control or kill micro-organisms that are not on this list then aren’t preservatives, but that is misleading. You may see these marketed as ‘preservative free options’ or ‘preservative alternatives’, but that too is misleading. Technically, any substance that controls or kills micro-organism growth in a cosmetic product is acting as a preservative; and the defining question is this: if you removed the so-called preservative alternative from the formula, would micro-organisms be able to grow? If the answer is yes, then the substance/s is acting as a preservative and it is misleading to market it as not being a preservative. Sure, it may serve other purposes in the formula, but it is acting as a preservative if its removal would lead to microbial growth.

• Myth #4: This preservative is not a preservative.

• The point is, there is no ‘1’ perfect preservative that suits every formulation type – they need to be selected to suit the formulation, its charge, all ingredients it contains, pH range including drift over shelf life and the increasingly strict ‘free from’ list of different consumer groups. This is why there are so many preservatives available – because without them, most formulas would be rendered unsafe.

Myth #5: Some preservatives are harmful.

You’ve probably heard that parabens will give you cancer. You’ve probably heard about formaldehyde releasing preservatives. What you probably haven’t heard is that there has been, and continues to be, ongoing and extensive investigation to ensure safe input levels of these, and all, preservatives in personal care products. There are strict input limits on the use of parabens, formaldehyde releasers and just about every preservative used in personal care actually! The EU database has the most extensive list of permissible preservatives along with limits to ensure safe use. They also have several Scientific Opinions that have considered cumulative daily exposures of various preservatives to ensure consumer safety. If its considered safe in the EU, you can be sure of its safety within the specified limits in your personal care products, even on cumulative daily exposures.

Myth #6: There are preservative in my functional/active materials, so that’s enough.

No, it’s not. Some functional and active materials come with preservatives present to protect them from microbial contamination during storage – but they are used in small amounts in the raw materials; so, when they get added to a larger formula, they are no longer in amounts that are sufficient to protect the finished product. Every formula containing sufficient water needs broad spectrum preservation, regardless of the preservatives present in other materials.

Why are preservatives so controversial?

Preservatives interfere with one or more of the following: cell membranes, enzyme function, protein structure or cellular metabolic systems. But let’s face it, that’s exactly why we use them… on micro-organisms. Perhaps it is lack of understanding by consumers and misleading fear campaigns by organisations that highlight their activity for bacteria and fungi as if it will have the same impact on us! But, we are talking about tiny microscopic organisms here compared to 70kg adults (or even 5kg babies!!!) Again, using these materials within the limits set, especially by the EU, helps ensure confidence and safe use in a finished formula.

Perhaps its pressure from consumers or marketing departments to avoid certain preservatives that makes formulators take risks in these otherwise very hospital environments? One thing is certain, an inadequately preserved formula is a greater risk to a company’s reputation than an unpopular preservative choice!

Now, if we can just get back to focusing on the needs of the formula and ensuring compatibility, we’d have a lot more choices for every formula…

Happy formulating!

Learn to formulate professionally with the Institute of Personal Care Science, all on-line, anytime, as close to you as your computer anywhere in the world!

Find out more or get started today: www.personalcarescience.com.au or email us: info@personalcarescience.com.au

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By George Deckner, UL Prospector

Metal oxide-based sunscreen formulations have become very popular in recent years as alternatives to “chemical” sunscreens and are globally approved as sunscreens. Micronized Titanium Dioxide, Zinc Oxide and chemical-based sunscreens all work in a similar manner by absorbing UV radiation.

Advantages of using micronized metal oxides in sunscreens

• Better positioned as “natural”
• Globally approved
• Less irritating and penetrating than chemical sunscreens
• Often positioned for babies and sensitive skin
• More SPF efficient than chemical sunscreens
• Very efficient at boosting SPF when combined with chemical sunscreens.

Disadvantages of using micronized metal oxides in sunscreens

• Formulations are very process sensitive
• SPF can decrease over time due to agglomeration of metal oxide particles.
• High levels of metal oxides can cause a dry skin feel and whitening
• Need to use coated Titanium Dioxide and Zinc Oxide to reduce photo/chemical reactivity and improve skin feel
• Cannot be used in the US with Avobenzone
• Difficult to formulate facial day wear SPF products with good skin feel using more than 3% metal oxide

Metal oxide particle size

The most important property of metal oxides is their particle size. In formulations, metal oxide particles never exist as primary particles or their manufactured particle size but as clusters called aggregates and agglomerates.

An aggregate consists of primary particles fused together and can’t be reduced without using very high energy ball milling. The typical agglomerate contains clusters of aggregate particles held together by weak forces which can be reduced with roto stator mills and the use of good dispersing agents.

The primary particle size will normally determine the UV-absorbing and skin-whitening properties since it correlates with the aggregate size.

Micronized metal oxides need to be coated to reduce their chemical reactivity, especially for Titanium Dioxide. Uncoated Titanium Dioxide can form highly reactive free radicals when exposed to UV and can react with formulation ingredients causing discoloration and off odors. The coatings also improve the dispersibility of metal oxides in the water or oil phase of emulsions and improve wash resistance (for hydrophobic coatings).

The best coatings for Zinc Oxide are Silica and Triethoxycaprylylsilane and for Titanium Dioxide Silica, Alumina, with or without Dimethicone. However, there are numerous marketed Zinc Oxide formulations that use uncoated Zinc Oxide.

SPF boosters can be useful to significantly increase the SPF efficiency of metal oxides and primarily work by increasing UV absorption or increasing UV light scattering. All the top-performing marketed metal oxide-based sunscreens use SPF boosting technology (based on SPF efficiency).

Working with metal oxides

Supplier-made dispersions are preferred. If you make your own dispersions, they should be made as a separate premix that is added to the finished formulation using powdered metal oxides, dispersing agents, and high shear processing.

Learn more about formulating metal-oxide based sunscreens and get some material recommendations in the Prospector Knowledge Center

At in-cosmetics Asia in 2015, Belinda Carli, Director of Institute of Personal Care Science looked at evolution of regulations in nanotechnology.

Interested or concerned about the use of nanomaterials in personal care formulations? Attend this session to find out:
• How nanomaterials are regulated in personal care products around the world
• Opinions on the safety of nanomaterials
• Potential uptake and pathways within the skin
• Current issues associated with their use
• Latest scientific findings
• What to tell marketing and concerned consumers

This presentation will take a look at nanomaterials in everyday personal care products as well as those used specifically in sunscreens; and how to create novel formulations whilst enhancing performance, ensuring safety and maintaining compliance.

Come back to this news page weekly to see a new Marketing Trends & Regulations presentation that was taken at the show: news.in-cosmetics.com

Video taken at in-cosmetics Asia – The leading exhibition and conference in Asia for personal care ingredients – takes place in Bangkok in November – more info at www.in-cosmeticsasia.com