Making up rules

C&I Issue 7, 2007

Manufacturers assure us that cosmetics and other personal care preparations are safe. The number of reported health incidents is ‘one in many million’ product uses, according to the European Cosmetics, Toiletry and Perfumery Association (Colipa).

But consumers do suffer adverse reactions from time to time. Skincare and hair products are a common cause. Although users can develop a reaction to almost any ingredient in theory, fragrances, preservatives and hair dyes most often give rise to allergies. As well as acute instances, some consumers are left with a life-long intolerance to specific substances that could be found in any number of products.

The Council of Europe (CoE) agrees that allergies are increasing, with ‘allergic contact dermatitis being one of the most frequent undesirable effects of cosmetic products’. CoE announced plans in November 2006 for a cosmetovigilance scheme, similar to international pharmacovigilance systems to monitor adverse drug reactions.

CoE pilot studies in Austria, Denmark, France and Norway suggested that barely 25% of consumers with even very unpleasant reactions consulted a physician. The CoE thinks national consumer safety officials should share data through the Intergovernmental Information Network for Cosmetic Products (Incos), and has created model reporting forms for healthcare professionals reporting adverse reactions.

Chris Nichols, president of the UK Society of Cosmetic Scientists, agrees that preservatives ‘and many other cosmetic ingredients, for that matter,’ have the potential to cause sensitisation given sufficient exposure. The greater the exposure to any preservative, the more significant the risk of adverse effects becomes.

Ahead of the game
But according to the UK’s Cosmetic, Toiletry and Perfumery Association (CTPA) director general, Chris Flower, industry already takes the issue of consumer safety very seriously. Companies have an obligation under the Cosmetics Directive to record adverse reactions to cosmetics, and make these data available to the competent authorities. ‘So in fact some sort of cosmetovigilance system has been in place for many years,’ Flower says.

Consumers also have access to this information, and can write, telephone or e-mail manufacturers with product queries. Producers must inform customers of any undesirable effects that have been reported. Company contact details for the European Union market are available online at

Colipa has taken steps towards cosmetovigilance, through a series of voluntary guidelines rolled out in 2006. ‘Colipa’s guidelines explain what to do when someone contacts you with a complaint, how you assess whether it was related to your product, and what you do in terms of recording it,’ says Flower. This ensures consumer complaints across Europe are handled consistently, ‘no matter which companies are involved’. Christina Farr, regulatory and technical sales director, Unilever personal care Europe, adds that the causality assessment is a scientific approach. But ‘to be 100% sure that you have a reaction to an ingredient you have to have a patch test conducted by a dermatologist’.

As well as issuing guidelines, Colipa held a series of training days for national associations so that they could then train members. The guidelines and training have been popular. ‘In the case of our own association, we had every member send someone to be trained,’ Flower says. Companies are legally obliged to carry out these steps in any case, and companies appreciated Colipa’s harmonised approach.

European legislation
Cosmetovigilance is clearly a concept that’s gaining ground in Brussels, appearing in January’s 2007 European Commission (EC) consultation paper on the Cosmetics Directive as ‘a flow of information’ between dermatologists, industry, authorities and regulators on adverse effects from cosmetics. The consultation is the first step in a bid to simplify cosmetics legislation and strengthen elements relating to chemical safety. The current directive is ‘ripe for simplification’, including more than 45 amendments; it lacks definitions and coherent terminology, the EC says. The redrafted Cosmetics Directive or some of its annexes may be made into a regulation, a shortcut that spares all 27 Member States from transposing the legislation into national law. The revised directive is due in 2010.

The safety of products on the market in the EU is the responsibility of the person marketing them, assured through market surveillance. The surveillance comes under the remit of authorities in each member state. Currently in the EU, ‘positive lists’ exist for certain ingredients, such as colouring agents (although not those in hair dyes), preservatives and UV filters. These are groups of substances that have been shown through experience to raise serious safety concerns, and so each needs ‘authorisation’ to be allowed as a cosmetic ingredient.

The Scientific Committee on Consumer Products (SCCP) has increasingly scrutinised cosmetic ingredients, and either revised acceptable concentrations or banned certain ingredients outright. The Commission is looking at banning certain dyes, controlling ingredients containing iodine and examining new technologies incorporating nanotechnology.

Chemicals used in packaging and some cosmetic formulations will come under the new REACH legislation, too. The International Fragrance Association (IFRA) is concerned about the estimated €100m it will cost fragrance manufacturers to register the 35% of their ingredients affected by REACH. It also points out that fragrance manufacturers may encounter difficulties if some ingredient suppliers outside Europe decide it is too cumbersome to register certain chemicals and cease exporting them to the EU.

‘We don’t yet know whether there will be an impact on ingredient’s availability,’ says Flower. However, director general of Colipa, Bertil Heerink suggests that the cosmetics industry will benefit from the improved data availability that will result from REACH. ‘We are downstream users and we need data,’ he says: ‘It’s a matter of confidence.’

International ingredients
With output worth over €35bn, Europe’s cosmetics industry leads the world, directly employing over 150 000 Europeans. The EU cosmetics market is larger than the US market, and twice the size of the Japanese market.

In the US, cosmetics – unlike drugs – are not subject to pre-market approval, establishment registration, or ingredient reporting. The Food and Drug Administration’s (FDA’s) legal authority over cosmetics is more limited than its powers over pharmaceuticals, with only colour additives subjected to pre-market approval. The FDA can, however, investigate cases where products or firms break the law.

Under the federal system, states can specify their own ingredients legislation. California’s governor Arnold Schwarzenegger pushed through the California Safe Cosmetics bill in 2005, requiring companies to notify the state when they include chemicals linked to cancer or birth defects in their formulations. The Cosmetics, Toiletries and Fragrances Association (CTFA) spent over $600 000 opposing the le- gislation, which was prompted by studies linking pregnant mothers’ phthalate exposure to birth defects. This in turn has led to US media speculation that perhaps the industry had something to hide.

Lack of harmonisation means that industry cannot sell products across all markets. In some cases, test methods, formulation, packaging and advertising requirements differ. ‘The EU has a list of approved colours, as does the US and Japan,’ Flowers says. ‘The number of colours common to all is relatively small.’

‘We’re concerned that any change to the Cosmetics Directive shouldn’t lead to a divergence between Europe and America, or Japan, or ASEAN countries,’ says Flowers, who hopes that instead it might prompt legislative simplification elsewhere. ‘Rather than a single market in Europe, a global market is the ideal.’

New and improved
Legislators everywhere are chasing a moving target. An important element of the cosmetics business, and one that also makes products so hard to pin down, is the level of innovation. With the exception of fine fragrances, many of which have been on the market for over 100 years, most cosmetic products have a lifetime below five years, with up to 40% of products reformulated or replaced each year.

Cosmetovigilance may enter legislation under the amended Cosmetics Directive. ‘We would hope that it would follow very similar lines to what industry is doing at the moment,’ says Unilever’s Farr. ‘It’s going to be a challenging time for industry and regulators.’

But will it help consumers? ‘In all honesty no,’ says Flower. ‘By the time the companies have already logged that the product is not going down as well as hoped, they would have changed it.’

As many as 40% of cosmetic formulations contain methyl, ethyl, propyl or butyl parabens; preservatives that have been used with low sensitisation rates for over 30 years. They are ‘without doubt the safest preservatives the industry has ever seen,’ says Chris Nichols, president of the UK Society of Cosmetic Scientists, despite reports – since discredited – linking the chemicals to breast cancer.

Nichols is emphatic that the cosmetics industry should beware of ‘knee-jerk’ reactions against tried and tested ingredients. While consumer pressure has prompted industry to respond with products labelled ‘paraben-free’, he warns that replacing parabens with alternatives such as sorbic acid/potassium sorbate, currently used in 2% of US formulations, would increase sorbate exposure more than 18 times. ‘Sorbates are known sensitisers, so we can predict the effect this will have in the skin clinics.’ A similar picture would emerge for any other common preservative substitute, Nichols suggests.

‘The cosmetics industry has two options: It can either continue to bow to the slightest public pressure, real or perceived, and remove ingredients that might have attracted some bad press; or it can accept that when it comes to the safety of consumer products, the industry probably has the majority of the expertise.’

Animal testing
The seventh amendment of the Cosmetics Directive, which is not up for renegotiation when the rest of the directive is simplified, introduced a ban on animal testing of cosmetic products from September 2004 and a ban on certain ingredient tests after March 2009 within the EU. A further batch of tests will be phased out in 2013.

The March deadline also prohibits the use of ingredients tested on animals anywhere in the world – so new ingredients developed and tested outside the EU may be unusable inside the EU. Similarly, ingredients tested using alternative methods in the EU for use in EU products could not be used in products outside the EU if this required them to be tested on animals – because this would make them unavailable for use in the EU product. It remains to be seen whether parallel markets will develop for cosmetic products, with innovation in one market not transferable to the other.

The cosmetics industry is unlikely to be ready for the ban, and commentators suggest that without investment in validation processes for alternative tests, we should anticipate a bottleneck. In addition, resources at the European Centre for the Validation of Alternative Methods (ECVAM) may be cut, exacerbating the problem.

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