Safety evaluation of cosmetics in the EU
Reality and challenges for the toxicologist
Dedicated to the late Christian Hodel
Marleen Pauwels , and Vera Rogiers
Dermato-Cosmetology and Pharmacognosy, Department of Toxicology, Vrije Universiteit Brussel (VUB), Laarbeeklaan 103, B-1090, Brussels, Belgium
Available online 20 May 2004.
Abstract
Council Directive 76/768/EEC, its seven amendments and 30 adaptations to technical progress form the basis of the cosmetic EU legislation today.
There are actually four key principles for safety in the cosmetic legislation.
(i) The full responsibility for the safety of cosmetics for human health is placed on the manufacturer, first importer in the EU or marketer.
(ii) The safety evaluation of finished products is based on safety of individual ingredients, more specifically on their chemical structure, toxicological profile and their level of exposure.
(iii) A compilation of information on each cosmetic product (dossier) must be kept readily available for inspection by the competent authorities of the Member State concerned. This information source, usually called a technical information file (TIF) or product information file/requirements (PIF(R)), contains, as the most important part, the safety assessment of the product undersigned by a competent safety assessor.
(iv) The use of validated replacement alternative methods instead of animal testing forms the 4th key principle for safety of cosmetic products on the EU market. The 7th amendment imposes strict deadlines for the abolition of animal in vivo studies on cosmetic ingredients.
These legal requirements induce a number of important challenges for the cosmetic industry and more specifically for the toxicologist involved as safety assessor.
Author Keywords: Cosmetic products; Alternative methods; Risk assessment; Animal experimentation; Regulatory safety testing; Safety evaluation
1. The EU cosmetics legislation
Today the European Union (EU) counts 15 Member States and within the coming months and years, a new wave of accessions is foreseen, in which at least 10 candidate countries intend to join the Union.
The core of the Union has always been the single market, meaning free movement of goods, services, people and capital from one Member State to another.
Viewing the differences that existed between the national laws on cosmetics, producers in the cosmetic field were obliged to vary their production according to the Member State for which the products were intended. Because of serious hinder to the trade in cosmetic products, direct effects were seen on the establishment and functioning of the single market. Consequently the need for regulations at Community level with regard to the composition, labelling and packaging of cosmetic products, became a necessity. Officially published in September 1976, the Cosmetic Products Directive ([76/768/EEC, 1976]) constituted a legal instrument for all the Member States as to the results to be achieved. However, as any other directive, it had to be transposed into the individual national legal frameworks, thus leaving a margin of manoeuvre as to the form and means of implementation in each Member State. Although the single market was the initial drive for its initiation, the main objective of the cosmetic European legislation has always been the safeguarding of public health.
Council Directive [76/768/EEC, 1976] consists of a body text counting 15 Articles, and eight Annexes. The latter contain an indicative list of cosmetic product types (Annex I), a list of officially recognized symbols (Annex VIII) and a number of lists containing substances linked to specific limitations when used in finished cosmetic products (Annex II: substances whose use is prohibited in cosmetics; Annex III: ingredients subject to restrictions; Annex IV: colourants; Annex VI: preservatives; Annex VII: UV-filters).
The Annexes are changed regularly through so-called ‘adaptations to technical progress’ in order to take account of recent scientific and technological findings and the opinions on cosmetic ingredients produced by the Scientific Committee on Cosmetics and Non-Food Products (SCCNFP). Within the last 27 years 30 updates have been carried out.
On their turn, the Articles are modified through so-called ‘amendments’ when changes of the basic philosophy or introduction of new policies become necessary. To date, seven amendments have been published.
Thereof, the 6th amendment ([93/35/EEC, 1993]) introduced a number of important modifications that can be summarized as follows:
? Adjusted definition of a ‘cosmetic product’.
? Establishment of a common nomenclature of ingredients used in cosmetic products.
? Compilation of an indicative, non-exhaustive inventory of ingredients.
? Stricter safety requirements.
? Requirement for labelling the ingredients and product function on the packaging.
? Information requirements for each finished cosmetic product (safety and efficacy).
? Notification requirement, information to poison information centres.
? Ban on animal testing for ingredients or combinations of ingredients from 1 January 1998 on, with a possibility of postponement in case alternative methods for animal testing have not been scientifically validated. Two postponements have been published: Commission Directive [97/18/EC, 1997] postponed the date till 30 June 2000 and Commission Directive 2000/41/EC (2000) added two more years, bringing the final date to 30 June 2002.
As a result of the limited progress in alternative method development and with the clear aim of pursuing the abolishment of animal testing for cosmetic products, the 7th amendment (2003/15/EC, 2003) mainly deals with an animal testing ban for cosmetics and their ingredients, combined with a marketing ban on ingredients and finished cosmetic products tested on animals. Furthermore, it deals with:
? Regulation of CMR (carcinogenic, mutagenic and toxic to reproduction) substances.
? Addition of data on animal testing to the information requirements for each cosmetic product as defined in the 6th amendment.
? Indication of the period after opening for cosmetics with a durability exceeding 30 months.
? Easy accessibility to the general public of the cosmetic’s quantitative composition (restricted to dangerous substances) and undesirable effects to human health.
? Addition of 26 allergenic compounds to Annex III, with the clear indication that they should be individually mentioned on the ingredients’ list on the label if their individual final concentration exceeds 0.01% in rinse-off or 0.001% in leave-on cosmetic products.
2. EU cosmetic safety evaluation and data requirements
In the current legislation on cosmetics, Article 2 and Article 7a set the scene for the safety evaluation of cosmetic products within Europe:
Article 2
A cosmetic product put on the market within the Community must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, taking account, in particular, of the product’s presentation, its labelling, any instructions for its use and disposal as well as any other indication or information provided by the manufacturer or his authorized agent or by any other person responsible for placing the product on the Community market.
And to be kept readily accessible to the competent authorities:
Article 7a (d):
Assessment of the safety for human health of the finished product.
To that end the manufacturer shall take into consideration the general toxicological profile of the ingredients, their chemical structure and their level of exposure ….
Article 2 clearly outlines the basic requirement for safety for human health of the finished product, whereby the full responsibility for that requirement is placed on the manufacturer, the first importer in the EU or marketer. Furthermore, the cosmetic legislation involves a post-marketing surveillance system, as opposed to the existing pre-marketing notification/authorization systems in place for dangerous substances, biocides, plant protection products, drugs, … ([92/32/EEC, 1992]; [98/8/EC, 1998]; [91/414/EEC, 1991]; 2001/83/EC, 2001). In the latter cases, industry is partly backed up by a preceding positive advice of the national competent authorities.
Article 7a not only imposes the requirement to have a certain information package readily accessible to the competent authorities, but also clearly indicates that the safety evaluation process of a cosmetic product should be based on the intrinsic properties of its ingredients. This will automatically imply a new and important role for the raw material supplier.
2.1. The European dossier requirement for cosmetic products
As stated in detail in Article 7a of the cosmetics legislation, a compilation of information on each cosmetic product (dossier) must be kept readily accessible for inspection by the competent authorities of the Member State concerned at the address specified on the cosmetic package. It should contain information on the qualitative and quantitative composition of the products, its physico-chemical and microbiological specifications, the method of manufacture, evaluation of its safety for human health, the name, address and qualifications of the safety assessor, existing data on undesirable effects on human health, proof of the effect(s) claimed and data on any animal testing performed relating to the development or safety evaluation of the product or its ingredients.
This complete data package is called a technical information file (TIF) or product information file/requirement (PIF(R)) and practically spoken, it usually consists of the following four major parts (Rogiers, 2001 and Masson, 1999):
1. An administrative dossier:
? Trade name of the product and responsible company, manufacturer or distributor.
? Product category (Annex I).
? Integral composition of the product.
? Identification of persons with ultimate responsibility.
2. An ingredients dossier:
? Identity(ies), supplier(s) and composition(s) of the ingredients.
? Details on manufacturer(s) and supplier(s) of the ingredients.
? Physico-chemistry and microbiology of the ingredients including the physico-chemical properties and the physico-chemical and microbiological inspections.
? Toxicity data including acute oral, dermal and inhalation toxicity; local toxicity, including skin irritation, eye (mucous) irritation, sensitization, photo-allergy and photo-irritation when relevant; repeated dose toxicity data, additional relevant toxicological data and available ecotoxicological data.
? First aid measures.
? Risk and safety instructions with EU labelling according to Directive [67/548/EEC, 1967] and specific labelling according to Directive [76/768/EEC, 1976] and/or national legislation(s).
? List of animal tests performed with the ingredient.
3. A finished product dossier:
? Fabrication of the product with place(s) of manufacturing, methodology, identification of person responsible for manufacturing.
? Stability of the product including physical and microbiological stability.
? Physico-chemical properties and microbiological data on the finished product including examinations.
? Safety data concerning the finished product including an overview of the toxicological data of the ingredients; the communication done with the national competent authorities and the poison control centres; toxicological animal testing performed on the finished product; toxicological tests using alternative methods; human tests performed on the finished product; an undersigned safety evaluation with the identification of the safety assessor and the appropriate credentials.
? Efficacy of the finished product: a summing up of the claims made, efficacy tests that have been carried out, additional information or argumentation.
? Packaging and labelling: this part, starting with an overview of the data on packaging and labelling of the ingredients, provides the labelling of the finished product, gives information on packaging materials and weight/volume, packaging procedures, identification of the batch number, checks on the end products and finally identifies the person responsible for packaging.
4. Follow-up dossier of the market: a good functioning post-market complaint system, where consumers can communicate eventual complaints must be installed. All undesirable effects on human health reported during use of the product and their follow-up by the responsible manufacturer or marketer, must be added to the dossier.
A key part of the finished product dossier is the safety evaluation of the product by the safety assessor. The Directive does not provide rules of procedure to be followed for this risk assessment exercise, thus leaving the competent safety assessor some freedom in evaluating the safety of the cosmetic product under consideration.
2.2. Risk assessment of the individual cosmetic ingredients
The EU cosmetics legislation literally states that for assessing the safety of finished cosmetic products, the manufacturer shall take into consideration the general toxicological profile of the ingredients, their chemical structure and their level of exposure (Article 7a. 1(d)). This implies that the risk assessment of the individual ingredients becomes primordial.
According to the actual cosmetic legislation in the EU, two distinct channels are operative for the safety evaluation of cosmetic ingredients:
1. The safety evaluation of cosmetic ingredients of relevance to Council Directive [76/768/EEC, 1976]. For these substances, either through their use and function or through scientific knowledge obtained over the years, concerns for human health have been expressed. Their toxicological files are evaluated by the experts of the Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP). They advise the Commission (DG Enterprise) on the inclusion of the ingredient in one of the Annexes to Directive [76/768/EEC, 1976].
2. The safety evaluation of any cosmetic ingredient present in finished products of relevance to the dossier of information required under Article 7a of the 6th amendment (TIF or PIR). The safety evaluation is done by a so-called safety assessor (Article 7a. 1(e)) in the context of the safety evaluation of a given finished product. The ultimate responsibility lays with the manufacturer, importer or marketer.
2.2.1. Safety evaluation by the SCCNFP
The SCCNFP is part of the Commission, namely of DG Sanco and is composed of highly qualified scientists from different Member States (actually being B, D, DK, E, F, H, I, IRL, N, NL, UK). The SCCNFP is an advisory body for DG Enterprise, that is responsible for the administration of Directive [76/768/EEC, 1976] including the 6th and the 7th amendment.
The procedure for safety evaluation (= risk assessment) of cosmetic ingredients currently applied by the SCCNFP consists of three phases:
(1) Hazard identification by analysis of the studies on a particular ingredient, developed by the cosmetic industry and presented to the Commission (by individual firm(s) and/or through Colipa, the European Toiletry and Perfumery Association).
(2) Risk assessment by evaluation of the recent literature and all studies available with respect to the different toxicological aspects of a particular ingredient under consideration, thus allowing the evaluation of the safety levels for consumers potentially exposed to such chemicals as ingredients of finished cosmetic products.
(3) The requirement, in some cases, of additional toxicological tests in order to be able to make a reassessment of the safety profile of the ingredient under consideration.
The general toxicological requirements for cosmetic ingredients on the positive lists of the Cosmetic Directive [76/768/EEC, 1976] are summarized in the SCCNFP Notes of Guidance ( SCCNFP/0690/03, 20031) as follows:
1. Acute toxicity (if available).
2. Irritation and corrosivity.
3. Skin sensitization.
4. Dermal/percutaneous absorption.
5. Repeated dose toxicity.
6. Mutagenicity/genotoxicity.
7. Carcinogenicity.
8. Reproductive toxicity.
9. Toxicokinetics.
10. Photo-induced toxicity.
11. Human data.
2.2.2. Safety evaluation by a competent safety assessor
The procedure for safety evaluation of cosmetic ingredients, present in a given cosmetic formulation, is carried out in the framework of the safety evaluation of that particular finished cosmetic product.
All relevant toxicological information is gathered via several sources: official instances, supplier’s Material Safety Data Sheets (MSDS) and/or CD-ROMs from individual companies, commercial databases including bibliographical as well as factual databases (Rogiers, 1999). A first problem is that MSDSs do not always exist, since they are not required when the substance/preparation is not classified in any danger class (harmful, irritating, toxic, …) ( [91/155/EEC, 1991]; [93/112/EC, 1993]; 2001/58/EC, 2001). A second problem can be encountered with some substances taken up in EINECS (European INventory of Existing commercial Chemical Substances), which are very old and therefore may have a very poor and incomplete toxicological data package.
On the contrary, ‘new’ chemical substances (placed on the EU market after 1981) are regulated by the 7th amendment of Directive [67/548/EEC, 1967] (dangerous substances) and do have a dossier ( [92/32/EEC, 1992]). Its content depends on the annual volumes placed on the market and, although the summaries of the studies included in the notification files are not confidential, it often is difficult to get access to this critical information.
All chemical, toxicological and technical information on the ingredients present in a particular finished product, are brought together in the TIF of that product. This TIF, together with all available information relevant to human exposure, is used by the safety assessor to elaborate the safety evaluation of the finished product (Table 1).
Table 1. Tools in safety evaluation for cosmetic ingredients and finished products (based on Rogiers, 1999)
The cosmetic risk to be evaluated usually is restricted to a local one and is centred on irritation (and photo-irritation if relevant) and immunobiological reactions (contact allergy and eventually photo-allergic reactions). Potential systemic effects can occur (Nater and De Groot, 1985) and should be particularly taken into consideration when considerable skin penetration and/or oral intake occur.
The safety assessor must indicate in an undersigned document whether a cosmetic product can be brought onto the EU market without risks to human health when applied under normal and reasonably foreseeable conditions of use.
3. New challenges in safety evaluation of cosmetics
With the implementation of the 6th and 7th amendment a number of new challenges came up in the safety evaluation of cosmetics. These can be summarized as follows:
1. Moving from in vivo to in vitro testing.
2. Urgent need for appropriate exposure data.
3. New role of raw material suppliers.
4. The need for appropriate training.
5. Ethical constraints in human testing.
6. Special problems for small and medium enterprises (SMEs).
7. Consumer concerns and risk perception.
3.1. Moving from in vivo to in vitro testing
Article 4 of the 6th amendment, stating that safety for human health must be guaranteed without animal tests of ingredients or mixtures of ingredients from 1 January 1998 on, on the condition that appropriate validated alternative methods, 2 are available, has recently been replaced by the provisions of the 7th amendment, indicating strict timetables for a marketing and testing ban of finished cosmetic products and their ingredients. More specifically, the 7th amendment imposes a prohibition of in vivo animal studies on cosmetic ingredients from 11 March 2009 on, with the exception of repeated dose toxicity, toxicokinetics and reproduction toxicity tests, which will be prohibited from 11 March 2013 on ( 2003/15/EC, 2003).
These strong provisions imply that, in order to assess the safety of an innovative cosmetic ingredient after 2009, there will have to be alternative methods available for a considerable battery of animal toxicity tests. Not only will these alternatives have to be validated by that time, but they will also have to enable the achievement of the same level of consumer protection. In addition, they will be restricted to replacement methods, thereby ignoring refining and reduction methods as possible alternatives. It is clear that this constitutes a huge challenge for scientists and the cosmetic industry.
Validation of alternative methods is co-ordinated at the EU level in Ispra, Italy at the European Centre for the Validation of Alternative Methods (ECVAM). Scientific advice on this validation process is subsequently provided by a group of experts from all Member States, called ESAC (ECVAM Scientific Advisory Committee). An alternative method must pass ESAC and get its approval, before it can be taken up in the actual EU legislation (Annex V to Directive [67/548/EEC, 1967]) and be advised for cosmetics.
In Table 2, a summary is given of the actual situation of validated alternative methodologies useful in safety testing of cosmetic ingredients. Table 3 shows a number of so-called valid alternative methods, 3 as used by major cosmetic companies for finished products, while Table 4 indicates the prospects for the immediate future derived from the methodological status of in vitro methods existing at the end of 2003.
Table 2. Actual situation of validated alternative methods and methods, considered to be equivalent to validated ones, useful for safety testing of cosmetic ingredients
WEC: whole embryo culture; MM: micromass test; EST: embryonal stem cell test.
Table 3. Some ‘valid’ alternative methods for finished products
HET-CAM: Henn’s egg-chorio-allantoic membrane test; BCOP: bovine corneal opacity & permeability test; RBC: red blood cell test; NRU: neutral red uptake test; SIFT: skin integrity function test.
Table 4. Prospects for the immediate future of in vitro methods useful for safety testing of cosmetic ingredients according to the methodological status existing at the end of 2003
According to the provisions of the 7th amendment to the Cosmetic Products Directive (2003/15/EC, 2003), the Commission has to establish before 11 September 2004:
? After consultation of the SCCNFP, a new Annex IX to Directive [76/768/EEC, 1976] on cosmetic products, listing all the alternative methods other than those taken up in Annex V to Directive [67/548/EEC, 1967] on dangerous substances, which can be used to evaluate the safety of cosmetic products and their ingredients.
? After consultation of ECVAM and the SCCNFP, timetables for the phasing-out of the various animal tests, keeping in mind the deadlines of March 2009 and March 2013.
This implies that Table 2 and Table 3, currently containing many refinement and/or reduction and only few replacement tests, will soon be updated with the most recent advances in alternative method development.
3.2. Urgent need for appropriate exposure data
As stated earlier, the safety evaluation of a finished cosmetic product is based upon the toxicological profile of the ingredients, their chemical structure and their exposure level. Therefore it is indispensable to dispose of sound exposure figures for the individual cosmetic product types. Every specific exposure scenario will be linked to a certain amount of substance that may be ingested or absorbed through the skin or mucous membranes (SCCNFP/0690/03, 2003).
Only some estimates of these exposures are stated in the present Notes of Guidance of the SCCNFP (SCCNFP/0690/03, 2003) and in a Dutch study on cosmetic exposure assessment performed by the RijksInstituut voor Volksgezondheid & Milieu (RIVM) ( Bremmer et al., 2003). More relevant exposure information is to be expected from Colipa in 2004, as exposure studies have just been initiated in different European Member States.
Harmonized exposure levels for the individual product types remain indeed very necessary.
3.3. New role of raw material suppliers
With the requirements of the 6th amendment to keep a TIF ready for inspection for the competent authorities and containing a safety evaluation based on the structure, toxicological pattern and exposure of the ingredients, the availability, substantivity and completeness of high quality toxicological data of raw materials and new ingredients became of key importance. Raw material suppliers, surfactant suppliers and speciality chemical suppliers should be made better aware of this problem. Moreover, they must be aware of the 7th amendment article dealing with CMR-issues and the provision that the quantitative composition of a finished cosmetic product, restricted to those substances considered as dangerous by Directive [67/548/EEC, 1967], must be easily accessible to the public.
Finally, in order to enable their customers to comply with all the cosmetics-related legislative requirements (Article 1.7. of Directive 2003/15/EC), the raw material suppliers will also have to disclose lists of all animal tests performed on the ingredients under consideration.
3.4. The need for appropriate training
All parties involved in the preparation of cosmetics, importation within the EU, supply of raw materials, safety evaluation, development or application of alternative methods, regulation, etc. should be appropriately trained by taking specific training courses in the safety evaluation of cosmetics.
Such a course existed at the national level in Germany and was organized by the Deutsche Gesellschaft für Wissenschaftliche und Angewandte Kosmetik. An academic course with a legal course certificate exists at the European level in Belgium at the Vrije Universiteit Brussel, Department of Toxicology (http://www.sciencedirect.com/science?_ob=RedirectURL&_method=externObjLink&_locator=url&_cdi=5177&_plusSign=%2B&_targetURL=http%253A%252F%252Fsafetycourse.vub.ac.be, December 2003).
3.5. Ethical constraints in human testing
By eliminating animal testing, the need for human testing is increased, especially since not every alternative method has a sufficient predictive value for human exposure.
Confirmatory safety tests are sometimes necessary and can be carried out in man. Ethical concerns, however, should be considered. In one of its opinions on testing on human volunteers, the SCCNFP came to the conclusion that confirmatory tests on humans can only be considered when the toxicological profiles of all ingredients and of the finished cosmetic product, based on animal and/or alternative methods, are available and have all been found favourable (SCCNFP/0003/98, 1998).
Human tests, however, should not be preferred to animal tests and cannot be considered as an alternative to the use of animals. The SCCNFP made guidelines for human volunteer testing of potential cutaneous irritant ingredients, finished products and potentially cutaneous sensitizing cosmetic ingredients (SCCNFP/0003/98, 1998; SCCNFP/0068/98, 1999; SCCNFP/0120/99, 2000).
3.6. Special problems for SMEs
Safety evaluation of cosmetics and the application of in vitro methodologies require specialized personnel, which often is not available in SMEs. This means that extra resources become necessary for advice by competent consultants and for in vitro testing by contract laboratories. The 7th amendment has aggravated this problem, which already came up with the implementation of the 6th amendment.
3.7. Consumer concerns and risk perception
Awareness of the consumer is a key issue, which should be taken seriously. A first way of informing the consumer, is through adequate labelling of cosmetics. Article 6 of the cosmetics legislation foresees that the following indications are to appear on the package and recipient of cosmetic products:
? Name and address of the manufacturer or distributor.
? Nominal content (weight or volume).
? Date of minimal durability if less than 30 months, period after opening if durability exceeds 30 months.
? Precautions for use.
? Batch number enabling identification of manufacturing.
? Product function, unless evident.
? Ingredient labelling in International Nomenclature of Cosmetic Ingredients (INCI).
? Symbol of Annex VIII for off-pack labelling (book plus hand).
The last three labelling obligations were introduced with the 6th amendment and are intended to provide useful information to the consumer.
In particular, the appearance of a complete ingredients list on the finished product was asked by the medical profession in order to offer the possibility to sensitized or contact allergy-sensitive patients to avoid contact with certain cosmetic ingredients.
All ingredients (except impurities) are listed in descending order of weight, down to the 1% level, with the exception of individual perfume/aroma components. They are allowed to being replaced by the wording ‘parfum’ or ‘aroma’, unless they: (1) belong to the list of 26 allergens recently taken up in Annex III to Directive [76/768/EEC, 1976] ( 2003/15/EC, 2003) and (2) their concentration exceeds 0.01% in rinse-off or 0.001% in leave-on products.
For amounts equal or below 1% random listing is allowed. Certain ingredients can be omitted through a confidentiality provision, but experience has learned that this is only seldomly done ([95/17/EC, 1995]).
Colourants are given as colour index (CI) numbers and may be listed randomly at the end of the ingredients list. More colourants than present in the product may be indicated by the sentence ‘may contain’ or ‘±’, giving the opportunity of using only one type of packaging for a number of differently coloured products of the same series (2003/15/EC, 2003).
In addition to the existing labelling requirements, the 7th amendment foresees additional consumer information by making the quantitative composition of every finished cosmetic product publicly available (at least for those ingredients that are officially classified in one of the danger classes through the chemicals’ legislation), as well as the undesirable effects to human health. The mandatory mention of the period after opening for cosmetics that are stable for more than 30 months, is also considered to be a useful piece of information for the consumer, although the practical framework for it is still missing.
The 7th amendment also offers the possibility to cosmetic companies to advertise that no animal tests have been performed on their products or cosmetic ingredients. The application of this provision, however, still needs to be further explained through a guidance document, which the Commission intends to issue in 2004 (2003/15/EC, 2003).
Finally, it is important to consider that risk perception by the consumer, although subjective and completely dissimilar from the scientific determination of hazard and risk, really does matter, since it can importantly affect the cosmetic market. A typical example was the ‘problem’ of the UV-filter 4-methylbenzylidene camphor, which was perceived by the general public and the Danish Ministry to be an endocrine disruptor having estrogenic activity which could damage human health and particular that of small children (Schlumpf et al., 2001 and Bolt et al., 2001), while scientific evidence showed that there was no need for any regulatory action to protect the consumer ( SCCNFP/0483/01, 2001).
4. Conclusions
The 6th amendment of the European Cosmetics Directive guaranteed safe cosmetic products on the EU market. This was for a great part due to the community decision to leave the experimenter and therefore also the manufacturer to their own responsibility. This has resulted in a refinement of the different evaluation criteria and also in better cosmetics.
A disadvantage, however, was and still is the heavy task for SMEs that are not really equipped to take such a high responsibility and to deal with the high costs resulting from the implementation of the 6th amendment.
New challenges are to come with the implementation of the 7th amendment involving a potential animal testing ban on cosmetic products and cosmetic ingredients in the EU, and a potential EU marketing ban of animal-tested cosmetic products. This piece of legislation pushes scientists and cosmetic industry toward a drastic change in attitude in the field of cosmetic safety evaluation, since within 10 years, the traditional approach using a standard battery of in vivo tests has to be fully replaced by a strategy of in vitro tests offering the same level of toxicological knowledge.
The approach of pushing legislation, without having the scientific knowledge advanced enough to replace all in vivo tests by relevant and reliable in vitro methods, appears to be quite threatening for the safety of cosmetics and their free circulation within, and especially outside the EU market.
It is true that in vitro methods should and will replace increasingly in vivo regulatory testing, but it would have been much wiser and more realistic to elaborate a balanced in vitro/alternative strategy for each category of cosmetic products, instead of imposing a strict time frame for non-animal methods, as is the case now through the 7th amendment.
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