ASIA: Japan decides to ban 19 substances used in medicated soaps

Following the US FDA’ s September announcement that manufacturers have one year to replace or completely eliminate 19 common antibacterial ingredients from their medicated soaps (antibacterial washes: hand, shower, facial cleansing products), the Japanese Ministry of Health, Labour and Welfare makes public its decision to also adopt the ban.

Triclosan and triclocarban, two of the most commonly used antibacterial ingredients, are amongst those banned from future manufacturing.

FDA has informed that the decision is due to insufficient data with regards to their safety when used daily over a long period of time, as well as to lack of evidence concerning their efficacy in preventing and spreading certain illnesses.

The agency announced that antiseptic products whose composition includes one or more of the ingredients listed below will now be considered new drugs which will require drug application and, therefore, approval prior to being marketed.

gavel

19 antibacterial substances have been banned by the US FDA and the Japanese MHLW:

  • cloflucarban
  • fluorosalan;
  • hexachlorophene
  • hexylresorcinol;
  • 6 individual iodophors (iodine-containing ingredients): iodine complex [ammonium ether sulfate and polyoxyethylene sorbitan monolaurate], iodine complex [phosphate ester of alkylaryloxy polyethylene glycol], nonylphenoxypoly (ethyleneoxy) ethanol iodine; poloxamer-iodine and povidone-iodine 5-10%; undecoylium chloride iodine
  • methylbenzethonium chloride
  • phenol (greater than 1.5%)
  • phenol (less than 1.5%)
  • secondary amyltricresols
  • sodium oxychlorosene
  • tribromsalan
  • triclocarban
  • triclosan
  • triple dye
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Europe: ban on the use of methylisothiazolinone in leave-on products approved

As of February 2017, leave-on cosmetic products containing methylisothiazolinone will no longer be allowed on the market.

A widely-used preservative in many personal care products, methylisothiazolinone has been associated with various allergic reactions.

The ban was proposed last year and will most probably be followed by a complete restriction in the very near future.

 

 

Why are the industries regulated?

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Regulatory Affairs is a sector born out of the need of governments across the globe to ensure the development and the delivery of safe and effective products to consumers and individuals in areas such as pharmaceuticals, medicines, medical devices, agrochemicals and cosmetics. 

The first to be regulated were the healthcare industries, with the diphteria epidemic leading to the 1902 Biologics Control Act in the United States, which regulated the sale of viruses, serums, toxins and similar products in the District of Columbia. Though initially dominated by the US, due to its technological forefront and market size, nowadays health ministries worldwide implemented directives, acts and regulations to control the safety of products, by making sure manufacturers comply with the minimum safety criteria established beforehand.

In Europe, the European Union started to harmonize the regulation of healthcare products in its member states in 1980, with the New Approach Directive to become the first major breakthrough in healthcare regulation in the region.

In Japan, the first regulation on production of non-regulated patent medicines (regulation of face lotions, toothpaste etc. not deemed to be patent medicines) or quasi-drugs was published in 1900. In 1960, the current Pharmaceutical Affairs Act was validated and the obligation to appoint a technical officer for cosmetics was installed. Seven years later, cosmetic quality standards and cosmetic ingredient standards were established.

Cosmetic products are subject to regulatory requirements in almost every country. In a century of constant innovation and rapid technological development, Health Ministries across the globe are continuously reviewing and updating laws, in order to ensure a high degree of consumer protection, while also helping minimize business impacts such as loss of sales, product recall or withdrawal.

 

US bans microbeads

The ban on manufacturing microbeads will enter into force on the 1st of July 2017. OTC medicines and cosmetics containing microbeads can no longer be manufactured starting July 1, 2018, with OTC drugs whose composition include the plastic microspheres, and had already been available on the market, still being allowed for sale until the 1st of July 2019.

Most commonly made of polyethylene, polypropylene and polystyrene, microbeads are widely used in cosmetics and personal care products as exfoliating agents. While very efficient in skin exfoliation, the main concern in regards to them has arisen from their impact on water.

Companies will therefore need to start focusing on finding less harmful alternatives to use in developing their products, as good for the skin, but better for the environment.

microbeads

Image Source: Peach Willow Spa

Zinc Oxide has been approved as a UV filter in Europe

Zinc Oxide has finally been approved as a UV filter! On the 22nd of October, the EU Standing Committee on Cosmetic Products has authorized Zinc Oxide as a UV filter, in both its nano and non-nano form.

UV filters are used to protect our skin from the harmful effects of UV light, and can be organic or inorganic. The organic filters absorb the ultraviolet light and convert it into heat; they are also the UV filter most commonly used, though their efficiency is rather low and are often supplemented with inorganic filters. Inorganic filters, depending on the size of the particles (the smaller the size, the more increased their efficacy is), can reflect, scatter and absorb the UV light, and protect against both UVA and UVB radiation.

Zinc Oxide powder

Zinc Oxide powder

Zinc Oxide, as well as Titanium Dioxide, are renowned broad-spectrum “active semiconductor photocatalysts used extensively in heterogeneous photocatalysis to destroy environmental pollutants that are organic in nature. They are also extensively used in sunscreen lotions as active broadband sunscreens that screen both UVB (290–320 nm) and UVA (320–400 nm) sunlight radiation and as high SPF makers. When photoactivated by UV light, these two particular metal oxides are, however, also known to generate highly oxidizing radicals” (Nick Serpone, Daniele Dondi, Angelo Albini,University of Pavia – “Inorganic and organic UV filters: their role and efficacy in sunscreens and suncare products”).

The list of UV filters allowed in cosmetic products in Europe currently comprises 28 substances and represents Annex VI of the EU Cosmetics Regulation EC 1223/2009. Zinc Oxide will be officially included in early 2016.

Crystal Structure of Zinc Oxide

The crystal structure of Zinc Oxide

Restricted and prohibited parabens in Europe

In April 2014, five long-chain parabens: isopropylparaben, isobutylparaben, phenylparaben, benzylparaben and pentylparaben were banned by the European Commission, under the recommendations of the Scientific Committee on Consumer Safety [Regulation (EU) No.358/2014]. Companies were given six months to place (new) compliant products on the market – deadline was October 30 2014, and fifteen to withdraw the existing non-compliant ones – action to have been undertaken by the 30thof July 2015.

In October 2014, new restrictions were imposed on butylparaben and propylparaben whose maximum allowed concentration has been lowered to 0.14% (as esters), “when used individually or together”. In addition, the two have been prohibited in leave-on products intended for the nappy area of children under three years of age. All new products made available to the consumers after the 16th of April 2015 have had to comply with the new requirements, whilst the cosmetics already placed on the market could still be marketed until the 16th of October 2015.

The EC’s decision is much related to the 2011 Danish ban concerning products designed for children under three, after which the SCCS was asked to investigate further.

Vials of Parabens

Vials of Parabens

However, the whole controversy surrounding parabens is not recent news and has arisen from an assumed critical endocrine-disrupting activity and endocrine-related toxicity of propyl and butylparaben and their iso compounds, and of benzylparaben (according to the SCCS, “these properties appeared to increase with increasing chain length”).

The debate has commenced in 2004, when three medical reports formulated by an oncologist stating to have found parabens in human breast cancer tissue were published. Even though the results had never been supported by any of the global scientific communities, the media rapidly embraced the story. The outcome? Consumer hysteria and consternation. On a global scale.

We all know that, while parabens might indeed have an “oestrogen-like” effect, those added to cosmetic formulations cannot go any deeper than the stratum corneum. Parabens are also easily metabolized so the body can get rid of them very quickly. They are present in cucumber, vanilla, olives, onion, carrots, they can be found in insects and animals, as well as in a precursor of coenzyme Q10 in humans – the para-hydroxybenzoate (parabens are esters of para-hydroxybenzoic acid). Even though the study might have indeed found that parabens can accumulate in tissues and that there might be a risk associated with them, no connection with the development of malign tumors could be established.

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They have been successfully used for decades for the preservation of foods and personal care products, due to their low cost, low toxicity, versatility, efficiency and tolerance rate. Since 2005, parabens have been evaluated by the Scientific Committee Consumer Safety various times. This final decision relating to their use in cosmetics was adopted on a worst-case-scenario hypothesis, as potential risk to human health could not be assessed due to inconclusive or lack of data.

This might have been one of the worst decisions ever made in regards to the restricted and prohibited cosmetic ingredient lists, since the catalogue of safe preservatives is not very generous as it is anyway; besides, I cannot see any movement towards providing innovative and safer alternatives. Even if, while the science evolves rapidly, it is still going to take years, maybe even decades, to complete assessments on the safety of new, innovative preservatives.

Meanwhile, people are encouraged to purchase paraben-free products, obviously by “free-from” advocating companies. It is hard to change the general consumer’s perception taking into account that the majority does not have the qualification to understand the science behind cosmetic ingredients, but I trust it won’t take long before they realize that free-from-parabens products are not necessarily better alternatives. Just because a product does not contain a paraben, it does not make it a healthier, more efficient, or a safer choice, as it can contain a series of much more dangerous ingredients disguised under the “free-from a, b, c” message on the label.

Looking forward to the day the Commission will take serious action against “free from” claims made by companies that take advantage of the lack of knowledge amongst consumers and of the fact that the legislation is very unclear in regards to the matter. But, well, that’s another story. In the meantime, we can only hope that the common user will also start making more informed choices. In the end, we should all avoid everything we have health concerns about, but what I cannot agree with is companies promoting paraben, silicon and other “chemical”-free products as a safe option, when we all know that, in most cases, this is just a marketing strategy to attract clients, increase sales and improve reputation.

parabenfreesenza-parabeniimages

More about the science behind this debate below (SCCS Opinion on Parabens, adopted in December 2010 and revised in March 2011):

http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_041.pdf

Amendments to the list of allowed preservatives in Europe – Methylchloroisothiazolinone (and) Methylisothiazolinone, Methylisothiazolinone

The European Commission Regulation (EU) No. 1003/ 2014 of September 2014 amended Annex V of the EU Cosmetics Regulation with respect to the use of methylisothiazolinone and of the mixture methylisothiazolinone (and) methylchloroisothiazolinone in cosmetic products commercialized in Europe.

The mixture methylchloroisothiazolinone (and) methylisothiazoline has been banned from leave-on products, to reduce the skin sensitisation/ allergy incidents.The Scientific Committee for Consumer Safety has, however, concluded that the previously-approved maximum concentration of 0.0015% of a mixture in the ratio 3:1 of methylchloroisothiazolinone (and) methylisothiazolinone) is still safe for use in all rinse-off cosmetics.

Methylisothiazolinone-3D-balls

Methylisothiazolinone

The maximum allowed concentration of methylisothiazolinone remains 0.01%, nonetheless it has been established that the use of methylchloroisothiazolinone (and) methylisothiazolinone is incompatible with the use of methylisothiazolinone alone in the same products as it would affect the 3:1 ration agreed upon precedently

Methylchloroisothiazolinone-3D-balls

Methylchloroisothiazolinone

The deadline for making available on the market new compliant products was the 16th of July 2015, while those already marketed can still be sold until the 16th of April 2016.

Image source: https://commons.wikimedia.org/wiki/User:Jynto

Cosmetic Products – definition and brief notes on how they are regulated in some of the world’s key-markets

The EU Cosmetics Regulation (which came fully into force in July 2013 repealing Directive 76/768/EEC) characterizes a cosmetic product as “any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours”.

 “The regulation gives consumers a uniform level of protection in a single market and brings unprecedented clarity for industry” – Bertil Heerink, director-General of Cosmetics Europe. While strengthening and harmonizing the requirements for safety, ensuring a higher level of consumer protection (all member states must comply with the same requirements, leaving no room for transposition), the new legislation has adopted a centralized procedure for the notification of all cosmetics placed on the EU market, implying less paperwork and allowing a free circulation of goods.

United States’ Federal Food, Drug and Cosmetic Act (FD&C Act), defines cosmetic products by their intended use – “articles, intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body, for cleansing, beautifying, promoting attractiveness, or altering their appearance”. As certain products fall under the definitions of both cosmetics and drugs, due to their intended uses, such products have to be compliant with the requirements of both categories. These are usually products possessing two intended uses: e.g. shampoo, which is a cosmetic, given the fact that its primary use is to cleanse the hair, while, if supplemented with a medical claim as “antidandruff”, it becomes a drug. Other examples include products with SPF claims, deodorants which are also antiperspirants, toothpastes with fluoride, essential oils intended for aromatherapy. On the other hand, cosmetics which claim to reduce or eliminate cellulite, regenerate skin cells, encourage hair growth or treat a skin condition are considered drugs.

Drugs are “articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals”.

In the US, cosmetics do not require a pre-market approval, unlike drugs which must receive one, either through the New Drug Application process, or conform to a “monograph” for a specific category of drugs, as set by the FD&C Act.

In Japan, the law describes cosmetics as “articles with mild action on the human body, which are intended to be applied to the human body through rubbing, sprinkling or other method, aiming to clean, beautify and increase the attractiveness, alter the appearance or to keep the skin or hair in good condition”. Cosmetics are classified into six categories:

  • Perfume and eau de cologne
  • Makeup products (foundation creams, lipsticks, eye makeup, and others)
  • Skin care (skin lotions, essences, skin milk, cleansing creams etc)
  • Hair care (hair dye, shampoo, hair treatment)
  • Special-purpose cosmetics (sunscreen, shaving cream)
  • Cosmetic soaps

Quasi-Drugs are defined as articles for the purpose of: preventing nausea and other types of discomfort; preventing heat rash, soreness etc; encouraging hair growth or hair removal, or exterminating and preventing mice, flies, mosquitoes, fleas etc. Products which fall under quasi-drugs: deodorants, depilatories, hair growth treatments, hair dyes, perm and straightening products, cosmetics with medicinal claims such as anti-ageing, acne treatments, products with whitening effects.

While the Ministry of Health, Labour and Welfare (MHLW), under the Pharmaceutical Affairs Law regulates the two beauty categories differently, in reality, the difference between cosmetics and quasi-drugs is still vague, unclear and questionable.

In South Korea, the Ministry of Food and Drug Safety through the Korean Cosmetic Products’ Act, places cosmetic products in two major categories: general cosmetics and functional cosmetics (anti-wrinkle, skin brightening, those which promote gentle tanning or protect the skin from UV radiation).

General cosmetics can be marketed after they have been registered by the manufacturer/ importer, but are subjected to post-marketing surveillance. Functional cosmetics though, have to undergo a strict evaluation on safety and efficacy and be approved by the MFDS. They cannot be imported prior to the ministry’s approval.

In South-East Asia, in order to facilitate the free movement of cosmetics in the ASEAN region and eliminate the technical barriers, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam have worked together and committed to a harmonized set of principles in regards to product safety, quality and efficacy. The ASEAN Cosmetics Directive follows the EU Cosmetics Directive, having established similar criteria for product safety and identical definition for cosmetics.