These new product safety regulations have recently been introduced. Are your products still in compliance?

In this article, you will learn about the FDA’s draft guidance on the recommended maximum limit for lead in cosmetics in the United States, revisions to Canada’s toy regulations and children’s jewelry safety regulations, updates to the SVHC list, and new regulations in Japan for small quantities of new substances.
Product Regulations Update
1 Food and Drug Administration (FDA) issues draft guidance on lead limits in cosmetics
Lead cannot be intentionally added to cosmetics as an ingredient, but because it is a natural heavy metal, often found in air, water, and soil, very low levels of lead are likely to be found in finished cosmetic products. On December 23, 2016, the FDA announced a draft guidance on the maximum lead limit in lip cosmetics and other externally applied cosmetics. The draft indicates that the recommended lead limit is 10 ppm, and the guidelines apply to lip cosmetics (such as lipstick, lip gloss, lip liner) and cosmetics for external use (such as eyeshadow, blush, shampoo, and body lotion). The deadline for comments on the draft is February 21, 2017, after which the FDA will prepare the final version of the guidelines. The guidance is likely to help ease consumers’ concerns.
Currently, the limit for lead in cosmetics exported to the United States is based on two California court rulings. However, the lead limits in the two court cases are different: one states that the lead limit is 5 ppm in lip cosmetics and 10 ppm in other cosmetics, while the other states that the lead limit is 0.35 ppm in lip cosmetics and 0.5 ppm in other cosmetics. There is no mandatory requirement to follow either case; clients may choose which one to follow.
Lead limits have now been elevated from state case law to the guideline level, which means that the FDA is paying increasing attention to the hazards of lead. Businesses are advised to apply stricter product standards to meet buyers’ requirements while avoiding the risks caused by differences between the guidelines and case law.
(Source: Intertek Health and Household Chemicals http://t.cn/RxAi6Sv)
2 Revision to Canada’s Toy Regulations SOR/2011-17
On November 25, 2016, Health Canada enacted SOR/2016-302 to amend the existing Toy Safety Regulations (SOR/2011-17). This revision mainly clarifies some of the existing requirements, updates test methods, removes redundant or outdated requirements, does not involve new requirements, and does not affect the existing toy industry or toy safety, or Health Canada's compliance and enforcement activities.
  1. Amend Section 26 requirements for irritant, corrosive, and sensitizing substances to clarify the definitions of “based on human experience” and “large population groups” during testing;
  2. Delete sections 27(1) and (2). The previous regulations stipulated that the specifications, quality, quantity, and proportions of substances such as resins, plasticizers, antioxidants, dyes, or pigments in plastic materials used to produce toys for children under 3 years old had to comply with the relevant requirements for food packaging materials and food containers. However, the current law does not include a positive list and therefore cannot be enforced, so these sections were deleted;
  3. Delete the phthalate requirements in section 27(3)(d), because Canada’s phthalates regulations already set specific limits.
  4. Delete the vibration and drop tests for toy batteries in Section 43 and Schedule 9, because developments in industry standards, battery structures, and technology have addressed these risks.
(Source: Xike Testing http://t.cn/RxyFCx7)
3 Canada plans to amend safety regulations for children's jewelry
On December 3, 2016, Health Canada proposed to publish draft regulations to revise the cadmium content in the Children's Jewelry Safety Regulations (SOR/2016-168). Key revisions include:
  • For parts that can come off easily and fit into the small parts cylinder (which can pose a swallowing hazard to children), the cadmium content must not exceed 130 mg/kg;
  • Replace the current 90 mg/kg migratable lead limit requirement with a 90 mg/kg total lead limit requirement.
The draft will be reviewed from December 3, 2016 to February 15, 2017.
(Information source: http://t.cn/RxysvXy)
4 ECHA officially added 4 substances to the 16th batch of SVHCs, bringing the SVHC list to 173 items
Helsinki, January 12, 2017: based on proposals from France, Sweden, Germany, and Austria, ECHA officially identified the 4 substances Bisphenol A, PFDA, PTBP, and 4-HPbl as Substances of Very High Concern (SVHCs), updating the SVHC list to 173 items. Substances included in the SVHC list may later be added to the REACH Regulation Annex XIV authorization list. At that point, after the sunset date, companies may continue to use them only if they apply for authorization.
If a product contains SVHC substances, it will be subject to a series of responsibilities and obligations. When the SVHC content exceeds 0.1%, the article manufacturer must provide downstream users and consumers with safety data sheets (SDS) or other substance information. As of January 12, 2016, manufacturers and importers of articles containing these substances must complete the notification within 6 months. We remind companies to stay updated on changes to the SVHC list and comply with SVHC-related responsibilities and obligations.
(Source: Xike Testing http://t.cn/RxysAfB)
5 Japan Chemical Substances Control Law | the first filing period for small-quantity new substances in 2017 is about to begin
On December 14, 2016, Japan’s Ministry of Health, Labour and Welfare, Ministry of Economy, Trade and Industry, and Ministry of the Environment jointly issued a notice on the first notification for small quantities of new substances in 2017. A declaration for small-quantity new substances refers to a declaration for cases where “the total annual import and production volume in Japan is less than 1 ton.” This declaration does not require a test report; you only need to complete a declaration form for small-quantity new substances. After the review is approved, a confirmation letter will be issued, and the company can use it to complete customs clearance procedures. The first filing period in 2017 for small-quantity new substances is from January 20, 2017, to January 30, 2017. After this filing is approved upon review, the legal activity period is from April 1, 2017, to March 31, 2018. There are four opportunities each year to file a notification for small-quantity new chemical substances, but if you miss the first filing period, the authorities will not accept the notification until the second filing period in June. To avoid disruptions to trade activities, companies are advised to prepare their dossier information as early as possible.
(Source: 华测瑞欧 http://t.cn/RxystD0)
Safety and compliance know-how
US releases annual toy safety report: risks in three types of export toys require attention
The Consumer Product Safety Commission (CPSC) recently released the “Annual Report on Child Injury and Fatality Data Related to Toys.” The report provides a statistical analysis of data on child safety incidents caused by various types of toys in the previous year and identifies multiple children’s products as high-risk products. The report states that under CPSC oversight, especially after the implementation of the Consumer Product Safety Improvement Act, the overall quality of toys sold on the market has been improving, but physical hazards such as mechanical injury, suffocation, and fire still pose major risks to children’s products today. According to statistics, throughout 2015, there were more than 250,000 child accidents caused by toys in the US market, including 11 fatal cases, involving various toys such as scooters, toy balls, riding toys, plush toys, balloons, and water guns. Among them, the three types of toys that caused the most injury incidents among children of all ages were Ride-Ons, toy balls, and flying discs. Given that the CPSC has previously taken measures such as sales bans and mandatory certification requirements on safety grounds for magnetic toys, electric twisting cars, and other products, the products identified as high-risk this time will certainly become a focus of the CPSC’s next phase of oversight.
In recent years, the CPSC has increased its oversight of products such as children's products by strengthening cooperation with agencies such as Customs and Border Protection (CBP), tightening safety standards, and requiring manufacturers to meet increasingly stringent safety requirements, putting tremendous pressure on businesses. The United States is the primary market for our country’s exports of children’s products, and the United States is widely regarded as a global bellwether for the regulation of children’s products. The continued strengthening of CPSC oversight has an impact on related export industries that cannot be ignored.
Experts from relevant departments remind exporters that preventing quality risks is key. On the one hand, they should continue to monitor domestic and international standards and regulatory developments related to children’s products, prepare responses in advance, and prevent safety risks at the source through structural design, raw material selection, and other measures. On the other hand, they should carry out testing and certification rigorously to ensure that products meet the applicable technical safety requirements and ensure quality and safety. At the same time, products should also provide prominent and detailed instructions for use and warning labels to avoid accidents, complaints, and other disputes caused by improper use by consumers, and to effectively reduce the risk of recall notifications. (Source: Yangguangwang)
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