Provisional Translation

OTO No. 652 Classification MHLW-(10)
Date of Acceptance July 24, 2002 Ministry/Agency Receiving Complaint Cabinet Office
Responsible Ministries Ministry of Health, Labour and Welfare Related Laws Law for the Control of Household Products Containing Harmful Substances
Complainant Embassy of Canada in Japan Exporting Countries Canada
Subject Relaxation of the regulation on formaldehyde contained in underwear for infants
Description of Complaint The Law for the Control of Household Products Containing Harmful Substances (hereinafter referred to as the Law) and its enforcement regulations provide for a regulation on the amount of formaldehyde contained in eleven items, including diapers, and textile products for infants not older than twenty-four months. (Differential light absorption must not exceed 0.05 when measured using the acetyl-acetone method.) And the Minister of Health, Labour and Welfare may instruct watchmen for household articles' hygiene to conduct on-the-spot inspections at factories, stores, etc., and when it recognizes the necessity, issue an order to collect articles that do not comply with the regulation.
An order was issued for a retail store to collect underwear for infants imported from Canada for the reason that formaldehyde exceeding the standard mentioned above was detected when watchmen for household articles' hygiene conducted an on-the-spot inspection. The retailer had obtained, however, when importing them, a certification that the standard mentioned above was met from a designated certification organization and claimed damages from the complainant, putting the blame on it.

1. Regulation
(1) The Japanese restricting amount (12-18ppm, when converted) is set at about half of those of other countries (30ppm in Finland and Norway), making it very different from them and inconsistent with international standards.
(2) It is said that the ministry is planning to revise the current test method so that the standard will be shown by the ppm unit like other countries. The complainant would like to know the specific timeline for its introduction.
(3) Current scientific knowledge does not make it possible to distinguish, as the cause of pollution, migration (surrounding chemical substances stick to products and pollute them) from resinous products (products themselves contain factors to create formaldehyde). Despite this fact, why do reports of inspection results often say, "it seems due to migration" that the products contain more of the substance than the standard allows, as the result of conducting the "method for distinguishing resinating and migration," which uses hydrolytic extraction of hydrochloric acids?
(4) Since washing in water noticeably decreases the concentration of formaldehyde, other countries with similar regulations prescribe the statement on the products that "consumers are required to wash them in water before use" and conduct measurement of formaldehyde after they wash products in water. The complainant requests the ministry to introduce a similar system.

2. Enforcement of Regulation
In the enforcement of the Law by local governments, in fact, foreign products are treated unfairly. The complainant would like to know the opinion of the ministry, as the authority in charge, about such a wrongful situation as well as its stance on taking measures and making improvements to put the situation right.

3. Inspections
(1) Test results differ greatly from one test organization to another. The ministry in charge is requested to take responsibility for standardizing test methods and prepare a manual for the enforcement of the Law.
(2) The complainant has information that the tests of three kinds of tags (accessories to the products) showed that formaldehyde was detected only in the tags of English of Canadian products. The conclusion is not built on science and shows the bias that Japanese products should have no problem. The complainant cannot help but judge that unfair treatment is being given to foreign products.

4. Others
The ministry should disclose information on the statistics and data of the results of testing sample purchases to enable case studies for investigating the causes aimed at preventing breaches, so that the number of breaches will be reduced.

(Second Opinion)
1. Regulation
The ministry is reportedly considering introducing a method to scientifically distinguish between the migration and resinating and treat them under different standards. Unless sources and points of time for the migration are identified, however, those responsible for the migration will remain unclear. Eventually, manufacturers or importers may be forced to take actions including recalling products. This apparently means no improvement. What is the ministry's opinion on this point? The complainant asks the ministry to specify details of administrative guidance for the causes (migration and resinating) of formaldehyde detection and how these details would change after the introduction of the method to distinguish between the migration and resinous products. While the Japanese formaldehyde standard of 12-18ppm can be clearly considered to be more rigorous than 30ppm in other countries, the ministry says it "does not think Japan's regulation is especially rigorous." The ministry is requested to specify the reason for this assertion.

2. Enforcement of Regulation
In an earlier reply, the ministry said that local governments had been notified of specific guidelines on the surveillance of the products for the enforcement of the Law. However, inspectors in local governments seem to be unfamiliar with inspections involving very low levels of formaldehyde. How has the ministry ensured that strict, fair sample purchases and inspections would be accurately implemented for all products distributed in Japan, irrespective of which countries produce them? How has the ministry monitored and assessed sample purchases and inspections by health care center officials regarding the important issue of health and safety for infants?

3. Others
1) While the Japanese and Canadian sides have thoroughly implemented all conceivable improvements, some importers or producers are still forced to voluntarily recall products. While willing to comply with Japanese standards, importers and producers have no more actions to take. The ministry is requested to specify effective measures, if any, for preventing formaldehyde detection.
2) The complainant is willing to look for ways to promote technical and information exchange and sisterly cooperation between Canada's Textile Technology Center and a Japanese organization undertaking tests and inspections regarding regulatory standards for household articles, and have the center's test results validated in Japan, if possible. The ministry is requested to give advice, if any.
3) The complainant wants to continue using the OTO process and have direct contacts with the ministry, especially divisions in charge of enforcing the standard in question. The complainant asks the ministry to specify any division for direct contacts and officials in charge of the matter.
Details of Measures The ministry replied as follows:
1. Formaldehyde has chronic toxicity and has been proven to have sensitizing potential at a concentration of only a few ppm through tests on animals, leading the ministry to set the standard to reduce exposure of infants to it on the skin and through the mouth as best as possible and prevent sensitization during the infantile period in which they do not have much resistance to chemical substances. The ministry will not refuse to review the standard if credible data are shown that prove a new standard will secure the same level of safety for infants, who do not have much resistance to chemical substances. Foreign countries have various levels of regulations of formaldehyde. The ministry does not think Japan's regulation is especially rigorous.
The ministry plans to introduce the indication of the standard by ppm within fiscal 2003 and is making studies on a new numerical standard.
When formaldehyde exceeding the standard is detected, it is very important in deciding whether the ministry should impose an administrative guidance to the manufacturer or the retailer to find out whether the formaldehyde comes from resinating or migration. The ministry understands that this is the reason for adopting, as a means of obtaining information on that, the "method for distinguishing between resinating and migration" by using hydrolytic extraction of hydrochloric acids, though it is not an official method. It is said that, to conclude that a product contains formaldehyde due to migration, many things must be taken into account, such as the comparison of measurement results of packed products and non-packed products and the existence nearby of a cause creating formaldehyde, making it impossible to reach a conclusion based only on the test method. The ministry understands that there are cases in which retailers are notified of the possibility of migration of the trial purchases coming from them as information for reference.
The standard of our country is set so that there will be no health damage even if consumers use them without washing them before use. As for the prescription of the statement on the products that "consumers are required to wash them in water before use," the ministry thinks, as Article 3 of the Law specifies, it appropriate for manufacturers or importers to do it as one of their obligations to prevent damage to human health.

2. The ministry sets restricting standards, test methods and standards for treating results and, in principle, entrusts local governments with actual works, such as sample purchasing and administrative guidance, as legally prescribed entrusted work. The ministry thinks local governments appropriately conduct the selection and purchase of samples to be tested, based on past cases of breach and experiences of purchasing samples.

3. The ministry thinks that test organizations that implement tests concerning restricting standards for household articles provide credible results, based on test methods specified in the enforcement regulations of the Law and the "Surveillance and Guidance Regarding Regulations for Household Articles (Planning Division Notice No.45 on March 10, 1981 by Director-General, Environmental Health Bureau, Ministry of Health and Welfare) and so on. The ministry thinks that individual test organizations should take responsibility for maintaining accuracy of tests to secure credibility of test results.

4. The ministry thinks that there is no problem in local governments taking responsibility for disclosing the results of tests of sample purchases to contribute to securing the safety of household articles.

(Second Reply)
1. The ministry is studying the possibility of introducing a method to estimate whether resinating causes formaldehyde, taking into account foreign systems.
As replied earlier, the ministry considers the Japanese standard to be appropriate. But it will not refuse to consider any credible demonstration data indicating that the same level of safety for infants, who do not have much resistance, is secured even at higher formaldehyde levels than the current standard.

2. As replied earlier, the ministry has set restricting standards, test methods and standards for treating results under Article 245-9 of the Local Autonomy Law, and thinks that local governments appropriately enforce the standard. The ministry also convenes an annual conference of local government officials in charge of safety for household articles for an exchange of information contributing to safety. Since administrative measures taken by local governments are reported to the ministry, it examines the appropriateness of such reports and compiles reference cases useful for surveillance that are provided to local governments.

3. The division in charge is the Chemical Substances Safety Office, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau.

(Actions taken by the ministry after the second reply)
The ministry consulted on the introduction of the indication of the standard by ppm and the addition of new test methods with the Chemical Substances Safety Committee held on October 1, 2003, and received a reply on October 14, 2003. The ministry plans to revise relevant ministerial ordinance by the end of fiscal 2004.
Classification of Processing Processed
(October 21, 2003) 		Directions I-a
I-b
IV
Remarks A written reply was made on August 1, 2002.
A written reply was made on December 16, 2002.
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