Regulatory Developments In Europe, there is only one product category for cosmetics, while in Japan the very same products are classified as either cosmetics or quasi-drugs. There is a significant difference between permitted efficacy claims in Europe and Japan, and ingredients on the positive list are different. In Europe, emphasis is put on post-marketing control instead of entry control. To promote the international distribution of products, the EBC urges the Japanese government to pro-actively work towards harmonisation of standards with Europe. Revision of the Pharmaceutical Affairs Law (PAL) represents the single most important regulatory development in this sector in Japan in recent years. The marketing approval holder license was created with a view to adopting best global practices. The Good Vigilance Practices (GVP) and Good Quality Practices (GQP) were introduced as requirements, emphasising post-marketing controls. For quasi-drugs, however, the entry control (i.e. marketing approval) and the discouragingly long lead time for approval remains. The EBC urges the Government of Japan to disclose information about substances already approved and shorten the application times for new approvals and partial changes in approved items. The requirement to undergo screening anew when introducing to quasi-drug products ingredients already used in cosmetics should be abolished. The list of 55 allowable cosmetics efficacy claims was announced in 2001. No new efficacy claim has been added since, and marketing advertisements are still tightly regulated. This restriction not only deprives consumers of important information when choosing a product, but also constitutes a disincentive for marketing approval holders to develop new products. False marketing claims could be more effectively restrained by applying the Act against Unjustifiable Premiums and Misleading Representations. The difference between the positive list of ingredients between the EU and Japan remains a critical issue. At the time of introducing the positive list in 2001, the Ministry of Health, Labour and Welfare (MHLW) issued a notification on the process for adding new ingredients, but this has proved to take too long a time. The EBC urges the European and Japanese Governments to establish procedures enabling swift and continuous addition to the Japanese positive list of new ingredients recognised in Europe. Prospects for EU-Japan Economic Integration Japan is the second largest market for cosmetics in the world worth about 1.4 trillion yen per year. The share of imports compared to domestic production continues to increase, with European companies accounting for a large proportion of imports. European firms, however, find it continuously difficult to expand their business due to the difference in standards for ingredients and permitted efficacy claims between Japan and the EU and the Japan-specific product certification procedures for so-called quasi drugs. Priorities
Key Issues and Recommendations ■ Reform of
quasi-drugs approval system Recommendation:
■ Reform of cosmetics regulatory system Yearly status report: no progress. Compared to the EU, where manufacturers may make efficacy claims according to scientific data, the general nature of permitted claims in Japan makes it extremely difficult to differentiate and market new products. The list of permitted efficacy claims has not been changed since 2001 when it was expanded to cover 55 claims, leaving a difference in the scope of cosmetics between Japan and the EU. The positive list of ingredients in Japan and the EU is different, repeatedly hindering the introduction of European products into Japan. The cosmetics importation scheme introduced in the revised PAL 2005 has made the importation of cosmetics cumbersome and directly contradicts the supposed guiding principle for all regulatory reforms - "efficient e-government". Despite the strengthened regime, many products imported and sold under false representations by companies that clearly do not meet GVP and GQP standards are still circulating on the Japanese market. This situation should be improved to ensure the quality, efficacy and safety of all products in market circulation for the sake of consumers. Recommendation:
■ Establishing alternatives to animal testing Yearly status report: some progress. The cosmetics industry worldwide is currently working towards developing alternative methods to animal tests following the EU Cosmetic Directive. The EBC appreciates the stance on alternative testing expressed by the MHLW in July 2006, and asks the Ministry to ensure that the capability to review data generated by alternative methods in an appropriate and swift manner is set up. Recommendation:
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