Product Safety Law

Evaluation of Alleged Unacceptable Formaldehyde Levels in Clothing

This report provides test results and discussion of an investigation undertaken by the Ministry of Consumer Affairs on alleged unacceptable formaldehyde levels in clothing.

Purpose of Report

1. This report has been prepared following an investigation of formaldehyde levels in a sample of clothing and manchester. It describes:

• Background leading to the investigation
• The applicable legislation regulating product safety
• The investigation methodology
• Background on formaldehyde, its use and possible sensitivities to its use
• Acceptable limits of formaldehyde in clothing and textiles
• The Test results
• Evaluation of Test results
• Working with Retailers and Suppliers
• Concluding Comments.

Background

2. On 19 August 2007, the Sunday Star Times ran a story stating that unsafe levels of formaldehyde in clothing had been identified through investigations undertaken by the television consumer issues programme Target. This was followed by the screening of the Target television programme on 21 August which stated that clothing being sold in New Zealand has formaldehyde levels in excess of accepted safe levels. The basis of these allegations was sample testing of 9 clothing items (both children and adult items). The allegations by Target received widespread publicity both in New Zealand and internationally, suggesting that New Zealand product safety standards and monitoring were not adequate.

3. Immediately on becoming aware of the issue, the Ministry of Consumer Affairs indicated publicly that it would begin an investigation to identify the scope of the issue and appropriate action. The Ministries of Consumer Affairs and Health also provided information to consumers on washing and airing clothing prior to use as a precautionary measure.

4. On becoming aware of the allegations, the Australian Competition and Consumer Commission (ACCC) also committed to a similar investigation in Australia. Various retailers also committed to their own investigations and sought assurances from their suppliers about any formaldehyde levels in clothing and other textiles supplied to them.

Legislation regulating product safety and requirements concerning formaldehyde in clothing and textiles

5. The Consumer Guarantees Act 1993 is the overarching legislation that provides for the general safety of goods and services to consumers. The Act creates a statutory guarantee that goods must be of acceptable quality and fit for the particular purpose for which they are supplied, including that products must be safe to use.

6. The other relevant consumer legislation is the Fair Trading Act 1986. Section 29 of this Act provides for product safety regulations: relating to the performance, composition, contents, manufacture, processing, design, construction, finish or packaging of the goods; the testing of the goods during or after manufacture or processing; and the form and content of markings, warnings or instructions to accompany the goods.

7. Section 31 of the Fair Trading Act provides for the Minister of Consumer Affairs to issue unsafe goods notices where it appears that goods of any description or class will or may cause injury to any person. The Act also allows for compulsory product recalls if goods are of a kind which will cause injury to any person and for product safety standard regulations.

8. Where unsafe goods notices or product safety regulations are in place, the Commerce Commission and NZ Customs both have responsibilities to police compliance.

9. There are currently no specific unsafe goods notices or regulations limiting formaldehyde in clothing and textiles.

10. The government has decided to issue a government product safety policy statement that sets out the limits of formaldehyde in clothing and textiles considered acceptable by the government. The policy statement is intended to provide clear guidance to manufacturers and importers as to acceptable limits of formaldehyde. The draft statement is to be released at the same time as investigation findings are released and will be finalised late 2007 following receipt of submissions.  The acceptable limits set in the draft statement are based on those used by the Ministry to assess its test results. The basis for these limits is outlined later in this evaluation report.

Investigation Study

11. The Ministry of Consumer Affairs, the Environmental Risk Management Authority and the Ministry of Health determined an appropriate methodology for investigating whether formaldehyde was present in New Zealand clothing and textiles above acceptable limits.

Sample Size

12. A sample size of 100 clothing and textile items was chosen.

Sample Collection

13. Samples were sourced directly from a range of retailers. Samples were obtained off the shelf and purchased in a process replicating how a normal consumer would go about shopping. This approach was taken to both replicate a normal shopping situation and to negate the possibility of any suggestion that samples may have been subjected to retailer tampering. The samples were collected by Measurement and Product Safety Officers (Ministry of Consumer Affairs) from Wellington retailers. An exception to this approach was required to obtain some of the clothing items sampled by Target (which were no longer available for retail purchase and were thus sourced from the suppliers directly).

14. The samples selected were as follows:

• 7 of the 9 items tested by Target that could be sourced.
• 19 infant items, including infant blankets and sheets.
• 66 popular selling products, made up of: 22 women's items, 20 men's items, 13 children's items and 11 other textiles.
• 8 items that represented goods that are most likely to have been treated with high levels of formaldehyde containing resins, including items made of rayon, blended cotton, corduroy, wrinkle-resistant 100% cotton, shrink-proof wool, synthetic blended polymers (e.g. polyester-cotton), heavy stiff fabrics and goods marketed as "permanent crease" or not requiring ironing.

15. Items collected were also sourced to ensure as far as possible (given the other requirements) that they came from a range of countries of origin generally present on the New Zealand market.

16. The samples bought were 84% from China, 7% from New Zealand and 9% from other countries. Samples were from a set of mostly cheaper to mid priced retailers.

Determination of Formaldehyde testing methodology

17. The testing methodology selected was EN ISO 14184-1:1998 Textiles – Determination of Formaldehyde – Part 1: Free and Hydrolyzed Formaldehyde (Water Extraction Method. This is a method for determining free formaldehyde and formaldehyde extracted partly through hydrolysis (reaction with water) by means of a water extraction method. The procedure is intended for use in the range of free and hydrolysed formaldehyde on the fabric between 20ppm and 3500ppm. Below 20ppm the result is reported as "not detectable".

18. This is the standard testing method used internationally for testing to textile formaldehyde standards.¹ It tests for free formaldehyde on the basis that adverse health effects from formaldehydes in textiles are likely to be skin reactions to "free or easily hydrolysable" (reacts with water) formaldehyde.²

19. Bound formaldehyde used in textiles may slowly leak over time but at a very low rate. Scientific research suggests that as bound formaldehyde is contained within a molecule it leaks at such a rate that it is unlikely to affect even those who are formaldehyde sensitive. As far as we are aware, there are no countries that ban the use of bound formaldehyde in textiles.

Testing laboratory

20. With advice from the Ministry of Health, the Environmental Risk Management Authority and International Accreditation New Zealand (IANZ), the Ministry of Consumer Affairs commissioned AgriQuality to test whether commonly purchased clothing and other textiles may contain excess levels of formaldehyde.

21. AgriQuality was asked to undertake formaldehyde release testing of 100 clothing and textiles samples using EN ISO 14184-1:1998. In addition to specifying the testing method used, the Ministry of Consumer Affairs' testing protocol allowed for post-wash testing of garments where appropriate.

Some background on Formaldehyde

22. The Australian National Industrial Chemicals Notification and Assessment Scheme³ has identified that the critical health effects of formaldehyde exposure from any sources are:

• sensory irritation via inhalation exposure to formaldehyde gas (vapour), aerosol or mist;
• skin sensitisation following dermal exposure to formaldehyde solutions; and
• carcinogenicity via inhalation exposure to formaldehyde gas (vapour) or mist.

23. Formaldehyde is classified as a hazardous substance under the Hazardous Substances and New Organisms Act having a number of hazardous properties, including skin and eye irritation, skin sensitisation and carcinogenicity.

24. Formaldehyde resin products used in the textile industry include printing inks, dyes and textile finishing products. The concentrations of free formaldehyde in these products are generally less than 2%.⁴ These formaldehyde-based materials help bind dyes and pigments to fabrics, prevent colours from running, improve a fabric's resistance to wrinkles, ease clothing care and maintenance and prevent mildew.⁵

25. Formaldehyde is also used, at low levels, in a variety of cosmetic and consumer cleaning products, in some medicines and dental products, and in some bank note paper. It is found in outdoor ambient air from combustion processes related to vehicles and from industry emissions. It is found in ambient indoor air from sources such as pressed wood (e.g., particle board), cooking and heating appliances and tobacco smoke.

Scientific studies of acceptable levels of formaldehyde in clothing and textiles

26. The adverse health effects from formaldehydes in textiles are likely to be skin irritations related to "free or easily hydrolysable (reacts with water) formaldehyde."⁶ However, the threshold level of formaldehyde on garments that will produce dermatitis is not known.⁷ Neither is the reaction threshold for already sensitized subjects. 

27. From the few studies located in recognised in scientific journals, the suggestion is that only a very few people (1-4%) are sensitive to formaldehyde concentrations of 1-2% and higher (10,000ppm-20,000ppm). For sensitised people, studies show decreasing reactions with decreasing formaldehyde concentrations but that even 30ppm may elicit a reaction, if only rarely, in some already sensitized subjects.

28. The Australian National Industrial Chemicals Notification and Assessment Scheme⁸ review notes that the European Union (EU) Expert Group on sensitisation categorised formaldehyde as a strong skin sensitiser. The review notes that formaldehyde solutions can induce skin sensitisation at very low concentrations and may elicit a dermatological reaction in individuals who have been sensitised. The skin sensitisation noted occurs from exposure to formaldehyde solution rather than to gaseous formaldehyde.

Determining acceptable limits of formaldehyde in clothing and textiles

29. In preparation for receiving and assessing the test results it was necessary to determine acceptable limits for formaldehyde in clothing and textiles against which the samples would be assessed.  In order to achieve this, the Ministry of Consumer Affairs examined both available scientific studies and considered the regimes operated by other jurisdictions. This research was peer reviewed by the Ministry of Health and ERMA.  On the basis of this research and peer review, the Ministry determined that it would use the following limits to assess the acceptability of the formaldehyde levels in the test results: 

• For clothes for babies and infants under 2 years of age: no greater than 30ppm;
• For clothing specifically designed and marketed as for people (both children and adults) with sensitive skin or to avoid any sensitive reaction with skin: no greater than 30ppm;
• For clothing and textiles in direct contact with skin: no greater than 100ppm, or 100ppm after wash if the label or instruction recommends to "wash before first use";
• For clothing and textiles not in direct contact with skin⁹: no greater than 300ppm.

30. As noted, the basis for these proposed limits included consideration of formaldehyde limits in place in other jurisdictions as set out below.

International formaldehyde limits in clothing and other textiles (parts per million (ppm))

31. There is also a voluntary New Zealand Eco-labelling Trust "Textiles, Skins and Leathers" labelling standard. Its requirements are "the amount of free and partly hydrolysable formaldehyde in the final fabric shall not exceed 30ppm for products that come into direct contact with the skin, and 300ppm for all other products". This eco-label is identical to European and other international eco-labels.¹⁰

32. The international regulated limits of formaldehyde in clothing and textiles show a fairly diverse spread. Japan has the most stringent limits, essentially no formaldehyde in baby and infant clothing and 75ppm for clothing in direct contact with the skin. There is some suggestion that these limits are a type of trade barrier, and in particular because the 20ppm limit is outside the limits of standard testing methodologies.

33. European laboratory experiments have shown that a level of 10 or less ppm formaldehyde in new infants clothing can be attributed to background formaldehyde levels that are not related to any textile finishing application. The European Union argues that a result between 10ppm and 20ppm allows for a qualitative statement about the presence of formaldehyde to be made, but only above 20ppm can quantitative information be given. Accordingly, in the European Union, if testing suggests below 20ppm then a zero level of formaldehyde is assumed. The European Union has noted that as other substances, for example, aldehydes give the same analytical response, only more expensive tests can assure that there are no disputes (exclusion of false positives). For that reason, and to avoid disputes, a test result of less than or equal to 30ppm is considered by the European Union as an acceptable lower limit.

34. This advice probably explains why Finland and Norway use this lower limit for textiles and clothing for babies under 2 years old and the very stringent eco-label has a lower limit of 30ppm detectable formaldehyde in textiles and clothing in direct contact with skin.

35. For textiles in direct contact with skin (children and adults), France, Finland and Norway have limits of 100ppm and the Netherlands 120ppm. For textiles not in direct contact with skin, Finland and Norway have limits of 300ppm and France 400ppm. The eco-label has a limit of 300ppm. These limits appear to be based on the scientific studies that indicate it is very rare for even sensitised subjects to have a reaction to formaldehyde below 100ppm; and reactions are rare also below 500ppm. The Netherlands provides that textiles designed for and labelled wash before use can meet a post wash test of 120ppm.

Government Product Safety Policy Statement

36. In order to provide clear guidance to manufacturers and importers, the government has agreed to issue a government product safety policy statement setting out what it considers to be acceptable limits of formaldehyde in clothing and other textiles. The statement is being released as a draft and will be finalised in late 2007 following the receipt of submissions. The limits used in the draft statement are those established by the Ministry of Consumer Affairs to assess its test results.

The Test Results

Below are the full test results sorted by

• Infants clothing
• Children's clothing
• Adult clothing
• Manchester

*less than 20mg/kg formaldehyde is deemed to be not detectable due to testing limitations.

Other test results

38. A number of retailers and distributors also commissioned their own random testing of their products for detectable formaldehyde. Of these, Farmers, K-mart, Pumpkin Patch and The Warehouse have shared their results with the Ministry of Consumer Affairs. 

39. From these combined tests which covered 203 items, only one was found to have above acceptable levels of formaldehyde. This item was a "pre-production sample" rather than stock available for sale off the floor. As a precautionary measure, however, stock was withdrawn from sale while further testing was undertaken. These tests have found that the product meets acceptable limits and as a result, the product has been returned for sale.

40. Given many products available in New Zealand are also available in Australia, as noted, following from the allegations by Target, the Australian Competition and Consumer Commission (ACCC) also undertook testing of a broad range of product samples in Australia for detectable formaldehyde. The ACCC tested both to EN ISO 14184-1:1998 and EN ISO 14184-2:1998. All of its samples gave a test result of non-detectable formaldehyde levels.

Evaluation of Test Results

41. The results of the tests commissioned by the Ministry of Consumer Affairs suggest that there is little cause for concern regarding safe levels of formaldehyde in clothing. The Ministry of Consumer Affairs test results show that 97 out of the 99 items tested were within acceptable pre-wash limits for formaldehyde in clothing and textiles with most registering non-detectable levels of formaldehyde (20ppm or less). All infants' clothing and all manchester tested had non-detectable formaldehyde (20ppm or less) and most adults clothing also had non-detectable levels of formaldehyde. 

42. Post-wash testing of the two adult items that "as new" tested above the acceptable limit of 100ppm found that the level of detectable formaldehyde fell to well below the acceptable limit after one wash.

43. In summary, the Ministry of Consumer Affairs' tests and the independent retailer testing combined covered 302 items. Of these items, only 2 or 0.7% were above the proposed acceptable pre-wash limits. Any potential health issues associated with these two items can be resolved by simply washing the garment before first use as recommended by the Ministry of Consumer Affairs and the Ministry of Health in their advice to consumers.

Working with Retailers and Suppliers

44. The Ministry of Consumer Affairs' investigation into formaldehyde levels in clothing and textiles has been facilitated by the extremely constructive response by the industry to its requests. Very early in the investigation the Ministry of Consumer Affairs met with representatives of the NZ Retailers Association, Farmers Trading Company, The Warehouse (New Zealand's two largest clothing retailers) and the New Zealand Textiles Council. The representatives were all very keen to cooperate with the investigation.

45. The Ministry of Consumer Affairs is working with the firms associated with the two items that met the proposed "post-wash" test limits.  Under the approach proposed in the draft Government Product Safety Policy Statement on Acceptable Limits of Formaldehyde in Clothing and Textiles, these items would need to be labelled "wash before first use". The Ministry is working with the firms associated with these products to confirm the testing results and reach agreement about appropriate action.

46. The Ministry of Consumer Affairs has also been very clear in its discussions with   the Retailers Association and individual retailers, that the expectation is that suppliers and retailers will be taking measures to assure themselves that clothing and other textiles meet the guidance set out in the Government Product Safety Policy Statement on Acceptable Limits of Formaldehyde in Clothing and Other Textiles once approved. This may be in the form of asking for assurances from international and local suppliers of clothing and textiles through to undertaking their own quality assurance testing. Some retailers such as Farmers operate their own testing laboratories and will look to consider adding tests for detectable formaldehyde in clothing and other textiles to the suite of tests they undertake.

Next Steps

47. In light of recent global developments and in particular the significant number of product recalls, New Zealand, like other jurisdictions around the world is reviewing its product safety regime with a view to more proactive enforcement and monitoring. The government has directed the Ministry of Consumer Affairs to advise on a more proactive approach to product safety monitoring, including resourcing requirements to support more proactive surveillance and testing activity.

48. As a first step, the government has agreed to a new mechanism for delivering good product safety outcomes - Government Product Safety Policy Statements. The first of these statements concerns Acceptable Limits of Formaldehyde in Clothing and Other Textiles, a draft of which is being released at the same time as this report. The intention of product safety policy statements is to provide clear government guidance to manufacturers and importers. They also will set clear limits against which the Ministry of Consumer Affairs Measurement and Product Safety Service will monitor to see whether there is compliance with the Government's stated expectations.

Conclusion

49. As a result of this investigation, the Ministry of Consumer Affairs does not consider that there is a problem with unacceptable formaldehyde levels in clothing available in New Zealand. It is concluded that further immediate testing is not needed.

Recommendation

50. It is recommended that you note this report and agree to its immediate public release.

Liz MacPherson
General Manager
Ministry of Consumer Affairs
 

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