Japan Further Strengthens the Supervision of Cosmetics Adverse Reactions

On February 26 2014, the Ministry of Health, Labour and Welfare (MHLW) announced in the MHLW Ordinance NO.13 an amendment to the Implementation Rule of Pharmaceutical Affairs Law and the GVP Ministerial Ordinance on Drugs, Quasi-drugs, Cosmetics and Medical Devices (GVP) regarding the reporting system of drugs, quasi-drugs and cosmetics. The amendment stipulates that cosmetics manufactures and retailers must report to the independent administrative corporation of pharmaceuticals and medical devices safety institution within a set time if the product causes severe adverse reactions. The new measure comes shortly after last years  ‘Kanebo scandal’ and is designed to prevent unpredictable health hazards caused by cosmetics at an early stage. The amendment  comes into force as of April 1 2014. After-market supervision of cosmetics will also be increased. 

Previously, cosmetics manufactures and retailers were only required to submit research reports without any documentation detailing potential cosmetic induced side effects. However, the amended Implementation Rule of Pharmaceutical Affairs Law expressly stipulates the inclusion of additional documentation which details the following:

• Cases that must be reported within 15 days of acknowledgement:
  • Death caused by suspected adverse reaction to Quasi-drugs or cosmetics
  • Severe cases or cases involving medical treatments.
  • Severe cases caused by adverse reaction that is noted in the instruction but not measurable in terms of  frequency of occurence. 
• Cases that must be reported within 30 days of acknowledgement:
  • Severe cases invoving known adverse reactions

Certain clauses such as ‘Quasi-drugs and cosmetics are exempt from the cosmetics safety reports’ are removed from the GVP. Under this ammendment cosmetics manufacturers and retailers will have to collect product safety related documentation from medical personnel or institutions. According to the MHLW, in certain circumstances if cosmetics manufactures or retailers cannot complete the adverse reaction report within the set time, they will then be required to submit the existing findings and to specify the expected date of completion and reasons for the delay.

Reference Link

Japan National Gazette