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| 7th Report of Market Access Ombudsman Council (March 18, 2002) |
1. Complainant: Canadian Embassy
2. Ministry concerned: Ministry of Health, Labour and Welfare
3. Complaint:
Under the Law for the Control of Household Products Containing Harmful Substances (Article 4-1), the Minister of Health, Labour and Welfare is authorized to designate home products from the point of view of public health and sanitation and prescribe necessary standards with regard to the maximum quantity, elusion and dispersion of harmful substances in home products. The Enforcement Regulations of the Law for the Control of Household Products Containing Harmful Substances regulates the maximum quantity of formaldehyde, a harmful substance, permitted to be contained in 11 of the textile products for infants of less than 24 months old, including diapers (Attachment 1 of the same Enforcement Regulations). The Minister of Health, Labour and Welfare is also authorized to dispatch home product sanitation watchers to factories and stores for on-site inspection and order the withdrawal of home products if necessary (Article 7 of the same law).
The complainant is an importer of infant underwear from Canada. The importer had imported underwear undergo product tests at an appointed inspection facility and obtained a certificate proving that the products in question meet the above standards. However, a retail shop was ordered to withdraw the products on the ground that a more-than-allowable amount of formaldehyde was detected as a result of an on-site inspection by a home product sanitation watcher. The retail shop in question claimed damages against the importer.
(1) The Japanese standard for the content of formaldehyde with respect to textile products for infants is that it should not be detected in such products. A large majority of the foreign countries do not have such regulations. Even if regulations are in place, they are much more relaxed than the Japanese regulations. For instance, in the Netherlands, the standard for the content of formaldehyde in baby clothes is less than 120ppm before washing in the case of no labeling that says, "Wash before use," or less than 120ppm after one washing. (See WTO Notice G/TBT/Notif.99.515, dated October 13, 1999) Moreover, since formaldehyde is soluble in water, it can be washed away if the product is washed.
Therefore, 1] The competent ministry should relax the standard by consulting standards in other countries. And 2] The ministry should present scientific grounds justifying the maximum permissible amount set by regulations. 3] The ministry should also present data concerning diseases caused by the minimum allowable amount of formaldehyde contained in baby clothes.
(2) When exporting products to Japan, we take good care of the products so that they meet standards. They passed product tests conducted by an appointed inspection facility at the time of importation, showing that they meet Japanese standards. However, we were forced to recall the products from retailers across the country on the ground that a more-than-allowable amount of formaldehyde was detected as a result of on-site inspection at a certain area. This may have been caused by the fact that formaldehyde exists in nature. The formaldehyde contained in the products was within the maximum permissible limit at the time when they were imported, but the products may have absorbed (migrated) formaldehyde due to poor management during storage, resulting in detection of a more-than-allowable amount of formaldehyde in on-site inspections of the retail shops.
Therefore, we would like the Ministry of Health, Labour and Welfare to explain 1] why the result of the test conducted by an appointed inspection agency at the time of importation differs from the result of the on-site inspection of retail shops conducted by the public health center, 2] why the testing method is divided into one for those less than 24 months and one for those over 24 months and why the methods are different, and 3] why the certificate issued by the appointed inspection agency at the time of importation is not effective. 4] We also want the ministry to apply the law flexibly. For example, even if more than an allowable amount of formaldehyde is detected in a product as a result of an on-site inspection of a retail shop, the ministry should approve the sale of the products in question after the cause of the contamination is clarified as a result of investigation of product management condition in the warehouse and after voluntary re-examinations of the remaining products are conducted and no problems are found, instead of issuing an order for across-the-board withdrawal of the products.
(3) Since around November 2000, we have undergone on-site inspection by a public health center almost once a month. Since this appeared to be more than the average number of inspections, we asked the Ministry of Health, Labour and Welfare and the public health center to present information concerning the products inspected. However, they replied that they do not have the custody of appropriate records.
Therefore, we want the ministry to show us data proving that on-site inspection is conducted impartially for any product of any country.
(Second complaint)
Regarding (1)
In the response, the Ministry of Health, Labour and Welfare says that the current standard for absorbance difference at "less than 0.05" is equivalent to "less than 15~20ppm." But this conversion seems to be arbitrary. For example, the Japan Textile Products Quality and Technology Center (QTEC) says in a report issued on September 26, 2001, that the absorbance difference of 0.05 is equivalent to less 15ppm. Based on this, it can be said that the Japanese standard (less than 15ppm) is far stricter than in other countries, where the standard is set at less than 30ppm.
The Ministry of Health, Labour and Welfare says the Japanese testing method seems to have caused a misunderstanding that it is zero restriction. Actually, it is widely believed that the Japanese method is zero restriction. As can be seen from the materials proclaimed to be a guideline, local governments and the ministries and agencies concerned also seem to view the Japanese method in the same way. Therefore, we want the ministry to confirm that it is not zero restriction.
The Ministry of Health, Labour and Welfare says that the Japanese regulation is based on the results of "experiments on animals." We want the ministry to give us detailed and specific explanations of scientific data, investigation and analysis methods, and, in particular, how 0.05ppm has come to be adopted as the standard.
With regard to our request for easing the standard, the Ministry of Health, Labour and Welfare demands reliable data. On the contrary, we want to ask the ministry if it has any reports showing that a maximum permissible standard of 30ppm has caused trouble in Japan or other countries.
Regarding (2)
As is clear from the results of experiments conducted voluntarily, the migration of formaldehyde that exists in the air cannot be avoided even under normal environmental conditions. The lack of means to distinguish migration in the testing method has made fair implementation of the regulation difficult.
The ministry says that since a product test conducted at the time of importation is a means of voluntary quality control on the part of the companies, test results are not legally binding. If so, why, in the case of some trouble, are importers asked by the public health center to submit the certificate issued by the inspection agency at the time of importation? Why, when they are not in possession of the import certificate, are they forced to submit a written apology to the public health center on the ground of inadequate management?
Although the state is responsible for the regulation, the actual implementation of the regulation has been shifted to local governments (regional public health centers). This has resulted in inconsistency in the implementation of the regulation. We think the regulation is still vague, inconsistent with the internationally accepted standard without any legitimate reason for being so, and implemented arbitrarily. Manufacturers and importers are making strenuous efforts to conform to the Japanese standard in such ways as promoting "zero formaldehyde campaigns" at factories. We think that the root cause of the problem is not the ways manufacturers or importers handle the matter, but the regulation itself.
In order to help product providers conform to the Japanese standard, we propose the following:
1] Japan should establish a standard that is in line with the internationally accepted standard in order to make it possible to conduct tests in a reliable way.
2] In order to ensure fair, impartial implementation of the regulation, officials of public health centers should be provided with the necessary training or the implementation of the regulation should be brought back under the control of the state.
4. Corresponding Policy of the Ministries concerned:
Regarding (1)
With regard to the permissible amount of formaldehyde in infant textile products, the Japanese standard requires that the absorbance difference as measured by the acethylaceton method be less than 0.05. This value, according to data accumulated through experiments, is equivalent to less than about 15~20ppm of formaldehyde content in samples. Although the regulation varies from one country to another, we don't think the Japanese standard is particularly strict as compared with those in Finland and Norway, where the comparable value is set at 30ppm. However, as to the testing method, which seems to have caused a misunderstanding that it is zero restriction, the ministry is considering indicating the standard in ppm as in other countries. The ministry is also studying revising the standard with a view to scientifically distinguishing migration (contamination of a product as a result of adhesion of a chemical substance in existence around the product) from resin-processed products (some products produce formaldehyde) and dealing with them separately.
The Japanese standard in question has been established from the standpoint of protecting, in particular, infants, who have little resistance to chemical substances, from being exposed to the substances through skin or inhalation, as experiments on animals show that formaldehyde has chronic toxicity and sensitivity even at a low concentration of several ppm.
The regulation is designed to protect infants, who have little resistance, from being exposed to formaldehyde by preventing the sale of products that do not conform to the standard. Although no particular disease has been reported under the current standard, we think it is important to ensure the safety of infants and prevent health hazard by maintaining the idea that led to the establishment of the current standard. If there are reliable data showing that the safety of infants can be ensured even when the formaldehyde concentration is higher than the amount restricted under the current standard, we will not rule out the possibility of reviewing the regulation.
Regarding (2)
Although the absorbance difference of most of the samples that are judged "not detected" by the acethylaceton method is from 0 to around 0.01, there are samples whose absorbance difference is only slightly below the 0.05 standard. This suggests that it is inevitable that the concentration of formaldehyde differs slightly among samples. Therefore, some samples in the same lot of "not detected" samples may contain formaldehyde exceeding the limit set by the standard. Although we do not have data for each case, the difference in test results pointed out by the complainant may be due to the unevenness in concentration.
As to the testing method, we have adopted a method based on absorbance difference, which is suitable for detecting elution of a relatively small amount of formaldehyde. This is because we have set the standard for the formaldehyde concentration in textile goods for infants aged 24 months or younger at a higher level than for adult wear from the standpoint of protecting infants who have little resistance to chemical substances.
Since the Law regulates only goods that are on sale, we regard a product test conducted at the time of importation, or before goods are put on sale, as a means of voluntary quality control on the part of the companies and test results are not legally binding.
As to administrative guidance by public health centers, etc. on withdrawal of merchandise, we have been implementing the guidance flexibly. For example, since formaldehyde concentration may exceed the limit set by the standard not due to the quality of the product but due to migration during custody, when a product purchased on a trial basis at a retail shop is found to have a formaldehyde concentration exceeding the standard, we purchase similar the product at other shops and check them in order to examine if the excessive concentration of formaldehyde is caused by the product itself.
Regarding (3)
The actual implementation of the trial purchase test and administrative guidance is basically entrusted to local government. The Ministry of Health, Labour and Welfare sets regulation standards, testing method, etc.
As to results of the trial purchase test, the Ministry of Health, Labour and Welfare receives only reports on the number of inspections conducted and does not have data on individual products by country.
In the last fiscal year, 5,744 cases were inspected and formaldehyde exceeding the standard was found in 71 (1.24%) of the cases. The ministry has received reports on the violation cases, including the exporting countries involved, and the reports can be made available.
(Second corresponding policy)
Regarding re-complaint (1)
As we have said in our previous response, with regard to the permissible amount of formaldehyde in infant textile products, the Japanese standard requires that the absorbance difference as measured by the acethylaceton method be less than 0.05. This value is equivalent to 12-18ppm of formaldehyde content in samples, according to data accumulated through experiments we have been conducting since last year as part of the preparations for the revision of the testing method. As we have said in the previous response, although the regulation varies from one country to another, we don't think the Japanese standard is particularly strict as compared with those in Finland and Norway, where the comparable value is set at 30ppm.
Rather, we think the problem lies, as was pointed out, in the facts that the Japanese method is widely believed to be designed for zero restriction and that it is difficult to scientifically distinguish migration (contamination of a product as a result of adhesion of a chemical substance in existence around the product) from resin-processed products (some products produce formaldehyde). Therefore, as we have said in the previous response, the ministry is now considering indicating the standard in ppm and revising the standard with a view to scientifically distinguishing migration from other incidents caused by formaldehyde-producing products and dealing with them separately.
The complainant demands that the ministry present more scientific data concerning the standard. But we believe that it is common knowledge among toxicologists that formaldehyde has chronic toxicity and that even just several ppm of formaldehyde may cause allergic reaction to an adult with a normal, healthy body. Moreover, the animal experiments that we conducted before the adoption of the standard show that formaldehyde has sensitivity even in a low concentration of several ppm. So, from the standpoint of protecting, in particular, infants, who have little resistance to chemical substances, from being exposed to formaldehyde through the skin, we have adopted the absorbance difference of 0.05 as the standard as it enables us to detect the elution of a relatively small amount of formaldehyde.
As we have said in our previous response, though no particular disease has been reported under the current standard, the regulation is designed to protect infants, who have little resistance, from being exposed to formaldehyde by preventing the sale of products that do not conform to the standard and it is important in order to ensure the safety of infants and prevent health hazard. However, if there are reliable data showing that the safety of infants can be ensured even when the formaldehyde concentration is higher than the amount restricted under the current standard, we will not rule out the possibility of reviewing the regulation.
Regarding re-complaint (2)
The public health center requests for submission of inspection results (certificates, etc. issued by the inspection agency) in the case of a violation of the standard in order to investigate the cause of the violation. It doesn't matter whether the voluntary inspection is implemented by manufacturers/importers or an outside inspection agency. However, since it is construed as a failure to confirm the safety of the product if one sells the product without implementing an inspection or with the knowledge that the product has been found to be in violation of the standard in a voluntary inspection, the public health center requests the submission of a written apology as part of administrative guidance.
As we have said in our previous response, regulations on formaldehyde vary from one country to another, but we don't think the Japanese standard is particularly strict as compared with those in other countries. We are aware of the problem that migration cannot be scientifically determined and therefore we are studying developing and introducing an improved testing method. As to the employment of the law by each local government, we have issued notices clarifying the guidelines on supervision and guidance. The law is not employed arbitrarily.
As to an improved testing method, we will make it known as soon as it is established.
5. Remarks
The complainant is now examining the matter.