Formamide Regulation in France and Taiwan

For Europe:

The formamide is proposing to be added in 2009/48/EC with limit for toys (playmat is included) as below 

Refer: http://ec.europa.eu/enterprise/tbt/tbt_repository/EU231_EN_1_1.pdf

While above propose is not effective yet, the Europe regulation for consumer product should be as below:

The marketing of puzzle mats containing formamide was restricted in some member States. Can formamide be used in toys?

Formamide is a CMR classified as reprotoxic cat 2 (or 1 B according to 1272/2008).

According to the current Toy safety directive 88/378/EEC, toys shall not contain dangerous substances in amounts which may harm the safety and health of children.
It is the responsibility of the manufacturer to demonstrate that toys they place on the EU market comply with this requirement. National market surveillance authorities have the obligation to verify and take measures the case may be.

The new Toy Safety Directive 2009/48 introduces, as from July 2013, a general ban on CMRs substances. As an exception, they can be used when they are contained in concentrations equal or below the concentrations mentioned in Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures (0.5% for formamide).

Refer: http://ec.europa.eu/DocsRoom/documents/5572/attachments/1/translations/en/renditions/native

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For France, the national regulation for puzzle playmat is as

Limit: <200 mg/kg

Refer: http://www.legifrance.gouv.fr/affichTexte.do;jsessionid=?cidTexte=JORFTEXT000026258509&dateTexte=&oldAction=rechJO&categorieLien=id

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For Taiwan, the national regulation for Toys and playmat are:

Limit: <2mg/kg (which is same as the withdrawed limit of France on 1 August 2012)

Refer: http://www.cnsonline.com.tw/?node=result&generalno=15493&locale=zh_TW

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The taiwan requirement was commented by European commission as below:

https://members.wto.org/crnattachments/2014/tbt/CHT/14_2983_00_e.pdf

http://ec.europa.eu/enterprise/tbt/tbt_repository/TPKM165_EN_1.pdf

Taiwan Helmet requirement

http://www.bsmi.gov.tw/wSite/ct?xItem=48826&ctNode=1510

Taiwan Children Puzzle Play Mats Safety Requirement

Bureau of Standard, Metrology and Inspection (BSMI) of Taiwan announced the safety standards CNS 15493 for the children puzzle play mats. The summary of the chemical requirement in CNS 15493 is summarized as below table: 

The harmful chemicals such as heavy metals, phthalates & PAHs etc could migrate to children body via the prolonged contact when children playing on the mat. The formaldehyde and VOC could also be released to atmosphere if used with large surface area in children room.

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For the children puzzle play mats, Belgium and France had also limited the formamide content before Taiwan.

And by the new Toy Safety Directive 2009/48/EC, the formamide was also be limited to < 0.5% in concentration. 

Regulated Chemicals:	Limit:
Formaldehyde	<0.3 mg/L
Formamide	£2 ppm
Migration of certain elements	Sb:£60ppm, Sn: £25ppm, Ba: £1000ppm, Cd: £75ppm, Cr: £ 60ppm, Pb: £90ppm Hg: £60ppm and Se: £500ppm
Phthalates	Total £0.1% (DMP,DEP,DEHP, DBP, BBP, DINP, DIDP, DNOP)
Polycyclic Aromatic Hydrocarbons (PAHs)	Ø   <1ppm – Benezo[a]pyrene
	Ø   16 PAHs, Total <10ppm
Total Volatile Chemical Compound (TVOC)	<0.19mg/m2．h
Azo Dyes (except non-textile mat)	< 30mg/kg
Free Formaldehyde (except non-textile mat)	< 20ppm

Taiwan Banned BPA in Infant Feeding Bottles

According to DOH Food No. 1021300776, Food and Drug Administration, Department of Health, Taiwan, Article 5 and 6 under Sanitation Standard for Food Utensils, Containers and Packages (食品器具容器包裝衛生標準) have been amended on 9^th April 2013. Bisphenol-A (BPA) in infant feeding bottles and its migration from certain plastic materials are regulated. Production, import and sale of infant feeding bottles and certain plastic materials containing BPA are prohibited in Taiwan to further protect consumers.

	Specific areas updated in standard	Effective date
Article 5 (Newly added)	Plastic materials that contain Bisphenol A shall not be used for the production of infant feeding bottles.	From 1st September 2013 on products manufactured or imported into Taiwan; Products existing on the market that do not comply with the new requirements shall be allowed until 1st March 2014.
Article 6 Test requirements of Food utensils, containers and packages: (Amended)	1)      Migration of BPA from articles (other than infant feeding bottles) made of polycarbonate (PC) shall be less than 0.6 ppm.  2)      Migration test of BPA from infant feeding bottles made of Polyphenylene sulfone resin (PPSU) and polyether sulfone resin (PES) was removed.

Taiwan proposed toys and children product standards update

Taiwan has amended the phthalates regulation from six phthalates （DEHP、DBP、BBP、DINP、DIDP、DNOP）to eight phthalates（added: DMP、DEP）from 2012.

Taiwan Toys & Children Product Safety Requirement

In Taiwan, CNS 4797 are mandatory requirement and the test will be done after the product enter Taiwan Customs. No other lab report out of Taiwan accepted, while some importor may have the pretest first.

經濟部標準檢驗局將積極辦理「玩具」及「兒童用品」管理措施

針對媒體刊載綠色和平組織於101年7月4日發布抽樣12件市售「兒童用品」商品檢驗結果，發現9件商品含有環境賀爾蒙壬基酚及不同種類之塑化劑。標準檢驗局表示，其中8件為標準檢驗局公告之玩具應施檢驗商品，「鄰苯二甲酸酯可塑劑」含量皆符合國家標準CNS 4797「玩具安全(一般要求)」之限量規定；另有4件為嬰兒推車雨遮及兒童雨衣屬兒童用品，目前非屬該局公告之應施檢驗商品，其中3件兒童雨衣之「鄰苯二甲酸酯可塑劑」含量超過國家標準CNS 15503「兒童用品安全一般要求」之限量要求，該局將即刻針對檢驗不合格之兒童雨衣發動市場購樣檢驗，以確保消費者權益。
標準檢驗局指出，為確保兒童使用玩具及兒童用品之安全性，已分別於相關國家標準中【包括CNS 4797玩具安全(一般要求)、CNS 6856筆擦、CNS 15503兒童用品安全一般要求及CNS 15527事務文具用品一般安全要求】規定8種鄰苯二甲酸酯類可塑劑及其混合物含量（DMP、DEP、DEHP、DBP、BBP、DINP、DIDP、DNOP）總和不得超過0.1%（重量比）限量值。
針對綠色和平組織發布可塑劑含量檢驗不合格之兒童用品，標準檢驗局表示將即刻發動市場購樣檢驗，不符合者將依「消費者保護法」相關規定查處。另有關該組織針對玩具及兒童用品檢驗「壬基酚」含量項目部份，標準檢驗局說明「壬基酚」常使用於紡織、塑膠、金屬、農藥等工業製程，目前國際標準及歐盟標準均未將「壬基酚」納入玩具及兒童用品之管制項目，該局將持續關注國際趨勢及相關資料，評估是否於相關國家標準中納入「壬基酚」之限量規定。
此外，標準檢驗局目前已將玩具、嬰幼兒紡織品、塑膠擦及兒童自行車等兒童用品列為應施檢驗商品，凡國外進口或國內產製之應施檢驗商品，均需經該局檢驗合格，並於商品本體或外包裝上貼附「商品安全標章」後，方可於市場上販售；倘檢驗不合格或違規逃檢者，該局將依商品檢驗法查處；而非屬應施檢驗品目之兒童用品，標準檢驗局亦每年擬訂市場購樣檢測計畫，倘檢驗不合格者，則依消費者保護法相關規定要求業者下架、回收處理，以雙重把關機制保護消費者之安全。而未來該局將逐年規劃可能影響消費者健康之兒童用品，優先列為應施檢驗品目。
而標準檢驗局也呼籲廠商進口或製造之玩具及兒童用品應符合國家標準規定，並請消費者購買玩具商品時，應檢查是否貼有「商品安全標章」及「中文標示」，以保障自身權益及安全。

Taiwan Phthalate Requirement updated

The BSMI of Taiwan has announced the update on CNS 4797 toys safety (general requirement), CNS 15503 children product safety and CNS 15527 stationary safety requirement.

DMP、DEP、DEHP、DBP、BBP、DINP、DIDP、DNOP, should have total less than 0.1ppm

臺灣標準局發現四分之一兒童洗澡玩具不符合鄰苯二甲酸鹽標準

臺灣標準檢驗局（Taiwan’s Bureau of Standards, Metrology and Inspection，BSMI）在對市場上銷售的兒童洗澡玩具進行調查後公佈了最終報告，調查顯示，經檢測20件兒童玩具中有5件不符合臺灣地區鄰苯二甲酸鹽限量標準。
根據規定，在臺灣銷售產品中的鄰苯二甲酸丁基苄基酯(BBP)、鄰苯二甲酸二異壬酯(DINP)、鄰苯二甲酸二異癸酯(DIDP)、鄰苯二甲酸(2-乙基己基酯)(DEHP)等七種鄰苯二甲酸鹽物質的使用限量應與歐盟標準保持一致。

摘自“WTO檢驗檢疫信息網2012年03月30星期五”

臺灣對嬰兒奶瓶中的BPA和鄰苯二甲酸鹽提出限量要求

2012年3月27日消息，臺灣省健康署（DoH）發佈了一項新的塑膠瓶化學物質限量要求，包括由聚碳酸酯、聚苯乙烯及其他材料製成塑膠嬰兒奶瓶。
按照限量規定，這類嬰兒奶瓶中使的增塑劑的鄰苯二甲酸二(2-乙基己)酯（DEHP）的可允許含量最高不能用超過1.5 ppm，鄰苯二甲酸二丁酯（DBP）的限量為0.3 ppm，雙酚A（BPA）的限量為30 ppb。同時，也對嬰兒奶瓶的標籤提出了新的要求。
此外，臺灣健康書也呼籲減少食品中增塑劑的使用，此前有實驗表明一些產品中含有過量水準的增塑劑鄰苯二甲酸二異壬酯（DINP）。

摘自“WTO檢驗檢疫信息網2012年03月30星期五”

Taiwan Toys Safety Standards CNS 4797 & CNS 15138

The Bureau of Standards, Metrology & Inspection (BSMI) of Taiwan announced in Feb 2012 on the update of CNS 4797 (Migration of certain element) and CNS 15138 (Phthalate on plastic toys).

The amendments are as below:

• CN4797: increases from 8 heavy metals to 19 heavy metals (same as 2009/48/EC)
• CN15138: increases from 6 phthalates to 8 phthalates (DMP & DEP, both are in risk assessment by the government)

The effective date is NOT yet confirmed.