Cosmetics & Quasi-drugs

Shipments of cosmetics in Japan were worth a total of 1,759 billion yen in 2019. In the same year, Japan imported cosmetics valued at about 282.5 billion yen, of which some 109.5 billion yen* came from Europe, indicating that European cosmetic and quasi-drug products are popular with Japanese consumers as they account for a considerable share of imports. The import process was made easier in 2016, when the Ministry of Health, Labour and Welfare (MHLW) abolished import notifications and eased the rules relating to Partial Change Approval for prescription drugs. It is now possible for the applicant to decide the timing of a product change. The EBC applauds the MHLW for these actions.

However, European companies still face challenges in bringing quasi-drug products to Japanese consumers in an efficient manner, due to Japan’s lack of regulatory transparency, the low degree of harmonisation between its product standards and those used in other parts of the world, and its unnecessarily complex approval and manufacturing requirements. As a result, the launch of many European cosmetic products in Japan is severely delayed, even when the same products are already in global use and have clinically proven efficacy. Some quasi-drugs even need to be reformulated because their global version uses new active ingredients or excipients for which obtaining approval is too time-consuming or difficult in Japan. European and Japan also maintain different rules governing which ingredients are allowed in cosmetics. Even if an ingredient does not require regulatory approval in Japan when used in a cosmetic, the use of the same active ingredient in a quasi-drug often requires a lengthy approval process. It is therefore considered to be difficult to deploy into the Japanese market promptly. Hence there is no choice but to change the ingredients in some cases. Furthermore, disclosure of information on effective ingredients and additives in quasi-drugs that are already approved in Japan is extremely limited, which is one of the reasons why such quasi-drugs require a long time to be introduced onto the market.

Parallel imports currently account for a substantial portion of the Japanese luxury cosmetics market. Some studies indicate that 11% of the units sold are parallel imports. Most are sold online via e-commerce portals. As these imports were not produced for the Japanese market, there is a risk that they are either not approved for Japan or do not have the proper labelling. There is also a risk that the imports may be expired products or products that have not been transported or stored properly and so could cause damage to consumers. The EBC calls on the Japanese authorities to make certain that all cosmetics sellers are subject to the same high standards when it comes to trader products, with a particular focus on formula registration, laboratory facilities, and labelling.

The EBC believes that Europe and Japan have an opportunity to lead the way in the global cosmetics and quasi-drugs market, by bilaterally negotiating faster registration of quasi-drugs, expanding efficacy claims, and harmonising ingredients that are allowed for cosmetics and quasi-drugs. In addition, the EBC would welcome greater leadership by European and Japan in the International Cooperation on Cosmetic Regulation, which meets to discuss how to promote multilateral regulatory coordination and harmonisation to minimise barriers to trade, while maintaining the highest level of global consumer protection. EBC strongly supports European and Japanese leadership in the ICCR.