In accordance with the requirements of Council Directive 76/768/EEC (Cosmetics Directive), the Commission presents the ninth report on the development, validation and legal acceptance of alternative methods to animal tests in the field of cosmetics. The purpose of the report is to:

presents the data on the number and type of experiments on animals relating to cosmetic products in 2009, as well as progress made in the development, validation and acceptance of alternative methods to animal testing in the Union and internationally; inform the European Parliament and the Council that for technical reasons full replacement of the animal tests covered by the 2013 deadline will not be achieved before 11 March 2013.

It is recalled that the Cosmetics Directive requires the Commission to put forward a legislative proposal in accordance with Article 251 of the Treaty if the Commission analysis concludes by 2011 that for technical reasons one or more tests referred to in the Directive will not be developed and validated by 2013. The report does not prejudice the decision on how to address the lack of non-animal tests.

Compliance with the testing and marketing ban: the report notes that the Cosmetics Directive provides for a phasing-out of animal testing for cosmetics. A ban on animal testing of finished cosmetic products has been in force since September 2004 and a testing ban on ingredients or combinations of ingredients since March 2009. As from March 2009, it is also prohibited in the EU to market cosmetic products and their ingredients which have been tested on animals, irrespective of the origin of these products. This marketing ban applies to all but the most complex human health effects to be tested to demonstrate the safety of cosmetic products (repeated-dose toxicity including skin sensitisation and carcinogenicity, reproductive toxicity and toxicokinetics), for which the legislator extended the deadline to March 2013.

Animal testing data : given that the testing ban for ingredients applies as of 11 March 2009, testing in line with the Cosmetics Directive was only possible between 1 January 2009 and 10 March 2009. In total, 344 animals were used in 2009 for tests carried out in relation to the safety of cosmetic ingredients. In the previous years, when testing was allowed during the entire period, the figures were 1.818 for 2007 and 1.510 for 2008.

According to the information received, cosmetic ingredients have only been tested on animals in Spain and France. These Member States provided detailed information, including the testing period, the toxicological endpoint, species of animals used for experiments and number of animals used for testing. The other 25 Member States reported that no such animal tests were performed in their territory in 2009.

Progress on alternative methods in the EU : endpoints falling under the 2009 deadline of the marketing ban are: skin corrosivity; skin irritation; dermal absorption; mutagenicity/genotoxicity; phototoxicity; acute toxicity; and eye irritation. .

Full replacement alternative methods are currently available for skin corrosivity, skin irritation, dermal absorption, and phototoxicity, while eye irritation, acute toxicity and mutagenicity/genotoxicity are only covered by partial replacement methods. For these endpoints the marketing and the testing ban apply fully. For mutagenicity/genotoxicity existing methods are being improved. For the two remaining endpoints, “eye irritation” and “acute toxicity”, progress is being made.

Accordingly, the report states that the overall conclusion and outlook is positive when looking at the developments since 2003, when the current provisions were introduced. Animal testing for cosmetics purposes in the EU is once and for all a thing of the past. The testing ban is well implemented and controlled.

Regarding the 2013 deadline, validated alternative methods will not be available for any of the three toxicological endpoints before the marketing ban enters into force. Thanks to serious efforts, a number of partial replacement methods are available. However, full replacement does not seem possible yet.

The Commission has presented its eighth report on the Development, Validation and Legal Acceptance of Alternative Methods to Animal Tests in the Field of Cosmetics. It reflects the state of play in terms of the number and type of experiments on animals relating to cosmetic products in 2007 and 2008, the current status of alternative replacement methods, and the acceptance and recognition of alternative methods at international level.

The main points are as follows:

Animal testing data: according to the information supplied by the 27 Member States, cosmetic ingredients have only been tested on animals in the territories of France and Spain. These Member States provided detailed information, including the testing period, the toxicological endpoint, species of animals used for experiments and number of animals used for testing. In total, 1818 animals in 2007 and 1510 animals in 2008 were used in tests carried out in relation to the safety of cosmetic ingredients. The total number of animals used for testing the safety of cosmetics showed a slight increase compared to the last report's figures for 2006 (2005: 2 276, 2006: 1 329). Nevertheless, the reported number of animals used for the testing of cosmetics or toiletries remains small compared to the total number of animals used for experimental and other scientific purposes.

Evaluation of submitted data: the majority of Member States replied that no animal testing in relation to cosmetic products was performed in 2007 and 2008 in their territory. The main explanations they gave to substantiate their replies were the following: i) national legislation prohibits the carrying out of animal experiments in order to test and develop cosmetic products and their ingredients and ii) national legislation stipulates that animal testing must be authorised in order to be lawfully performed.

Some Member States elaborated on their replies by mentioning the difficulties they had in collecting the information. In fact, the majority of animal tests are conducted for multiple uses by manufacturers of chemical substances (industry assumes that approximately 80-90% of cosmetic ingredients are tested for multiple uses).

In view of the efforts requested of the Member States by the Commission to deliver the appropriate information, some Member States described the measures taken to improve data.

This present report is the last report covering the period before the coming into force of the full testing ban for ingredients and combinations of ingredients for cosmetics and the marketing ban for all human health effects with the exception of repeated-dose toxicity, reproductive toxicity and toxicokinetics on 11 March 2009.

In view of the forthcoming marketing ban, Member States have essentially informed the Commission that they will use the market surveillance instruments in place in order to enforce the marketing ban. A number of Member States also planned to particularly draw the attention of market surveillance authorities to the ban through guidance notes and similar tools.

In conclusion, the Commission acknowledges that Member States have made efforts to improve the availability of data and that the overall availability has improved. However, the Commission continues to be concerned about the accuracy of the figures being reported , and this concern is shared by certain Member States.

The main issue relates to multiple use substances . Some Member States, when mentioning that no animal testing has been performed for cosmetic ingredients, reported that no toxicological tests were carried out for multiple or uncertain purposes where it could be considered that the substance might be used as an ingredient in cosmetic products. Legislation stipulating that animal testing must be authorised in order to be lawfully performed appears a useful tool to determine the purpose of testing.

The Commission presents its 7th report on the development, validation and legal acceptance of alternative methods to animal tests in the field of cosmetics. It reflects the state of play in terms of the number and type of experiments on animals relating to cosmetic products in 2005 and 2006, the current status of alternative replacement methods, and the acceptance and recognition of alternative methods at international level.

The salient points raised in this report are as follows :

Animal Testing Data : 26 Member States supplied information on animal tests carried out for the safety of cosmetic products in 2005 and 2006. Despite several requests, Portugal did not transmit any information. The Commission will consider opening infringement procedure.

According to the information submitted, cosmetic ingredients have only been tested on animals in the territories of France and Romania. These Member States provided detailed information, including the testing period, the toxicological test endpoint, species of animals used for experiments and number of animals used for testing. In total, about 2 276 animals in 2005 and about 1329 animals in 2006 were used in tests carried out in relation to the safety of cosmetic ingredients. The other 24 Member States reported that they did not perform such animal tests in their territory in 2005/2006 or that they cannot provide the information for the reasons explained in this report.

The total number of animals used for testing the safety of cosmetics showed a significant fall compared to the last report (2003: 1618, 2004: 8998). Indeed, the figures for 2006 are below those of 2003, even though twelve new Member States joined the EU in that period. The reported number of animals used for the testing of cosmetics or toiletries is still relatively small compared to the total number of animals used for experimental and other scientific purposes.

It can be noted that Member States have improved their internal structure in order to provide for accurate animal testing data and effective monitoring of the application of the testing and marketing bans, as it was encouraged in the guidelines annexed to the request to Member States for accurate data. However, the Commission continues to be concerned about the accuracy of the figures being reported, and this concern is shared by Member States.

The main issue relates to multi-use substances. Interestingly, some Member States, when mentioning that no animal testing has been performed for cosmetic products, reported that no toxicological tests were carried out for multiple or uncertain purposes where it could be considered that the substance might be used as an ingredient in cosmetic products.

The Commission will consider how further improve the availability of relevant information.

Development and Validation of Alternative Approaches : the report states that there currently four alternative in vitro methods in relation to three toxicological endpoints (skin corrosion, acute phototoxicity and skin penetration) listed in Annex V of Directive 67/548/EEC and one method for the mutagenicity testing listed under REACH. These alternative test methods are currently the only legally accepted tests at Community level aimed at fully replacing animal tests for toxicological endpoints in the area of chemicals and cosmetic products. A method concerning skin irritation is likely to be soon accepted for regulatory purposes. For eye irritation and acute toxicity, the situation is uncertain and the Commission will focus its efforts on these human health effects in view of the 2009 deadline.

For the 2013 deadline, the situation is much more critical.

For the endpoints falling under the 2013 deadline, there is unfortunately no indication that the deadline can be met for the complex endpoints, such as chronic toxicity, reproductive toxicity and toxicokinetics, although several activities are ongoing.

Lastly, the report underlines that the questions of validation and regulatory acceptance of alternative methods are also at the core of the various bilateral regulatory dialogues with the main trading partners (the United States, Japan and China).

This is the 6 th Report on the Development Validation and Legal Acceptance of Alternative Methods to Animal Experiments in the Field of Cosmetics. It analyses the number of tests on animals for cosmetic products in 2004. It also analyses alternative replacement methods and the acceptance and recognition of alternative methods at an international level.

Number and type of experiments relating to cosmetic products carried out on animals: The testing ban on finished cosmetic products has applied since 11 September 2004, whilst the testing ban on ingredients or combined ingredients will apply, step-by-step as soon as alternatives methods have been validated and adopted – but with a maximum cut-off date of 11 March 2009, irrespective of the availability of alternative non-animal tests. For this report, 23 Member States forwarded information to the Commission on animals tests carried out for safe cosmetic products in 2005. The UK and EL did not transmit any data given that they do not carry out animal tests dealing with cosmetic safety. According to the information submitted only three countries have conducted animal test for cosmetic purposes. They are France, Denmark and Spain.

In total about 9000 animal were used in tests – showing a significant increase: 9000 compared to 1618 in 2003. Part of this increase is attributed to growth in the cosmetic sector. In 2005, sales in the “old” 15 Member States, Switzerland and Norway reached EUR 60 billion in retail sales prices. A further reason for the large increase is that Spain did not transmit any data in 2003 but it did for the year 2004 and the increase in animal testing in France (from 1600 in 2003 to 5500 in 2004) is due to three additional test protocols being carried out by two laboratories.

The report does go on to point out that the reported number of animals tested for cosmetics or toiletries remains relative small compared to the total number of animals used for experimental and other scientific purpose. In 2002, for example, the then 15 EU Member States used a total number of 10.7 million animals for testing for scientific purposes.

The report considers, in some depth, the difficulty of obtaining accurate information from the Member States. The Commission notes that the information it received from the Member States for the present report demonstrates how difficult it is to generate accurate figures on animal testing in the field of cosmetics. Data on animal tests relating to cosmetic products are collated and generated differently through the EU. There is no uniform practice to collect animal testing data accurately.

Progress in the development, validation and legal acceptance of alternative methods: Currently, there are four alternative in vitro methods relating to two toxicological endpoints namely, skin corrosion and acute phototoxicity. These are the only legally accepted tests at Community level for the purpose of fully replacing animal tests for toxicological endpoints in the field of chemical and cosmetics.

A 2005 “Cosmetics Technical Report” indicated that efforts for the 2009 deadline look promising. For skin corrosion, acute phototoxicity and skin penetration, accepted replace assay already exist, whilst for mutagenicity accepted partial replacement assays exist. Significant progress is also being made in the field of eye irritation. For acute toxicity, the results of completed validation studies indicate the possibility of identifying non-toxic substances without the use of animals. Furthermore, as a result of work carried out under the 6 th Framework Programme, the proportion of substances, for which acute toxicity can be established, might be expanded in the near future.

For the 2013 deadline, however, the situation appears to be more critical. The Commission reports that it is highly unlikely that the chronic toxicity with any test strategy or battery of non-animal tests will be predicted. For reproductive toxicity some opportunities might emerge. Cancer bioassays are very unlikely to be requested for cosmetic ingredients since chemical identified as positive in mutagenicity/genotoxicity assays are usually abandoned. However, in case the carcinogenic potential needs to be evaluated, cell transformation assays, which are currently under validation, might be used. Promising alternative methods exist for skin and respiratory sensitisation.

Acceptance and recognition of alternative methods at international level: The OECD plays a prominent role in promoting and accepting alternative methods at an international level. OECD test guidelines have the broad approval of the international scientific community. The EU works closely with the OECD in the validation, acceptance and promotion of alternative methods. In 2004, the OECD adopted, for the first time, alternative methods aimed at replacing animal tests. The EU also plays a leading role in international regulatory dialogues with authorities in the US and Japan in order to facilitate the compatibility of cosmetics regulations and in order to avoid trade conflicts. In 2005, the EU and the US signed a Roadmap on co-operation for the development of alternative methods. Co-operation also extends to the Japanese Centre for the Validation of Alternative Methods (JACVAM), which was founded in December 2005.

Conclusions: The Commission doubts, based on the data it received from the Member States, whether all of the Member States have established mechanisms that provide for accurate animal testing data. As a result, the Commission is working on new guidelines that facilitate a more accurate compilation of data.

This 2004 report on the development, validation and acceptance of alternative methods to animal experiments in the field of cosmetics is the fifth report presented by the Commission. It reflects the state of play on the number and type of experiments on animals relating to cosmetic products between 1998 and 2003, the current status of alternative methods, as well as the acceptance and recognition of alternative methods at the international level as of December 2004. The report is produced in order to comply with Art. 9 of Council Directive 76/768/EEC (Cosmetics Directive), as amended by Directive 2003/15/EC. It is the first report on the basis of the 7th amendment to the Cosmetics Directive and after the inclusion of the Protocol on the Welfare of Animals in the Treaty of Amsterdam in 1999.

The last Commission report was presented in 1999 and covered the situation on the development, validation and acceptance of alternative methods to animal experiments in the field of cosmetics until 1997. This report includes data and information from the ten new Member States.

Firstly, the report details the number and type of experiments relating to cosmetic products carried out on animals. The 4th Statistical report showed the following:

- the total number of animals used was in the same order of magnitude as in previous reports. The total number of animals used in the EU Member States in 2002 was 10.7 Million - more than 60% of the 10.7 million animals were used in research and development for human medicine, dentistry and in fundamental biology studies, about 16 % in production and quality control of products and devices in human medicine, veterinary medicine and dentistry, and about 10 % for toxicological and other safety evaluation. From these 10 %, only 0.25 % (about 2600 animals) were used for toxicological or other safety evaluations of products/substances used or intended to be used mainly as cosmetics or toiletries.

For this report, information submitted showed that cosmetic products/ingredients have been tested on animals from 1998 – 2003 only in the territories of France, Italy and Denmark.. The other 12 old Member States did not perform such animal tests in their territory during this time period. The new Member States reported that they did not perform any such animal test in their territory in 2003;

- in total, the number of animals used for testing cosmetics in the old Member States of the EU decreased significantly from about 4200 to 1600 (1998 – 2003), although the total number of animals used in experiments increased in all sectors outside cosmetics and the market for cosmetics has continued to grow. Over the period 1999 – 2003, the Western European market (the EU-15 plus Norway and Switzerland) has grown by an average of around 4 % per year to increase to Euro 58,10 billion (retail sales prices) in 2003.

These figures on use of animals are unlikely to represent the full number of tests on substances used as cosmetic ingredients. There might be a number of reasons for this, e.g. the non-availability of comprehensive records on animal tests on substances used as cosmetic ingredients. Animal tests to assess the safety of ingredients are usually carried out on the basis of chemicals legislation, because they are normally used as industrial chemicals. Only in a few cases additional tests are necessary on the basis of the Cosmetics Directive. The cosmetic industry, as a downstream user of a number of such substances, mainly uses test data produced by the supplier under chemicals legislation in order to assess the safety of ingredients in cosmetic products. Therefore, it is difficult to get hold of accurate figure. The lack of accurate figures makes a comprehensive assessment of the use of animals in cosmetic tests difficult. The Commission will contact industry, Member States and other potential sources to clarify the matter and to establish a framework which would provide a more complete picture of animal tests carried out on ingredients used or intended to be used in cosmetic products.

Secondly, the report discusses progress in the development, validation and legal acceptance of alternative methods. In comparison with the last report from 1999, significant progress in this area was achieved. On 1 October 2004, the Commission established the timetables for the phasing-out of animal testing and set up an Ad Hoc Group of 75 scientific experts representing industries, academia, animal welfare groups and governmental bodies. The Commission goes on to discuss action under the 6 th framework programme on research and development, and private initiatives. It also discusses future activities.

Thirdly, the report looks at recognition of alternative methods on an international level. The manufacture, distribution and sale of cosmetics are a global industry within which the EU is a major player. The EU cosmetics and perfumes industry market volume, based on retail prices at the point of sales, amounted to nearly 50 billion Euro in 2000, compared to the US (EUR 30.7 billion) and Japan (EUR 14.3 billion Euro). Third countries represent significant and growing markets. In 2001, the export of cosmetics from the EU to third countries had a value of about EUR 7, 160 billion.

On the multilateral level, it is a major success that OECD adopted, for the first time in 2004, alternative methods aiming at replacing animal tests. OECD Test Guidelines are broadly accepted by the international scientific community and by appropriate regulatory authorities of OECD Member countries and a number of Non-Member countries. The European Centre for the Validation of Alternative Methods (ECVAM) is closely working with the OECD in the validation, acceptance and promotion of alternative methods. On a bilateral level, a key element of the EU-US cooperation is the implementation of the Guidelines for Regulatory Cooperation and Transparency agreed in June 2002. EU and U.S. agreed in June 2004 on a road map for further cooperation between the U.S. Food and Drug Administration (FDA) and DG Enterprise and Industry regarding alternative non-animal testing methods.

This is the Commission’s fifth report on the development, validation and legal acceptance of alternative methods to animal testing in cosmetics. It is, however, the first Report to assess the approximation of national laws relating to cosmetic products, as required by the seventh amendment to the Cosmetic Directive, (Council Directive 2003/15/EC). To recall, this amendment allowed, for the first time, the establishment of a clear and detailed framework for a ban on animal testing and on the marketing of cosmetic products and ingredients which have been tested on animals.

In preparing this study, the Commission refers to a 2005 Commission paper relating to the “Number of Animals used for Experimentation and their Scientific Purposes in the EU’s Member States”. The findings of that, earlier Report, indicate that in 2002 10.7 million animals were used for testing purposes. Only a fraction of that figure was used by the cosmetic industry. Based on information received from the Member States, the number of animals used in tests for cosmetic products decreased significantly between 1998-2003 down from 4200 to 1600. On the other hand, in all other areas of animal testing (research and human medicine, medicine and dentistry, fundamental biology etc.) the use of animal testing has increased. Moreover, according to information received by the Commission from the Member States, the only countries to have tested animals for the cosmetic purposes are France, Italy and Denmark.

As the Commission points out, however, the cosmetic industry is a “downstream” user of many ingredients. A large proportion of the ingredients used in cosmetic products are industrial in nature. In order to assess the safety of ingredients in cosmetic products, the cosmetic industry relies on data produced by their suppliers who, in turn have tested their ingredients, under chemicals legislation. It is, therefore, difficult for the Commission to assess the figures accurately, which makes it difficult to make a comprehensive assessment of the use of animals in cosmetic tests. The Commission promises to open a dialogue with the cosmetic industry on this matter in order to establish a more complete picture of animal tests carried out on ingredients used or intended to be used in cosmetic products.

As far as progress in the development, validation and legal acceptance of alternative methods is concerned the Commission notes significant progress, particularly when compared to 1999 findings. In 2005 the Commission established a timetable for the phasing-out of animal tests in accordance with the revised Article 4 of Directive 76/768/EEC. Together with the Ad Hoc Group of 75 scientific experts the most valuable and/or advanced alternative methods currently known vis-à-vis toxicological tests have been identified. It is expected that these will become law before the cut-off-dates in 2009/2013. Indeed, some human health effects can already be assessed using alternative methods and relate mostly to conditions such as skin corrosion, skin absorption and acute phototoxicity.

Lastly, the manufacture, distribution and sale of cosmetics are a global industry. The EU’s cosmetics and perfumes industry market volume, based on retail prices at the point of sales, amounted in 2000, to some EUR 50 billion compared to the US EUR 30 billion and Japan’s EUR 14.3billlion. An estimated EUR 7 160 billion was exported to third countries in 2001. The acceptance of alternative methods at an international level is therefore of clear importance to the EU cosmetics industry. One of the major breakthroughs reported by the Commission is the OECD adoption of alternative methods aimed at replacing animal tests given that alternative methods have the broad support of both the scientific community and the regulatory authorities.