To ensure product compliance, you need to pay attention to the five new US and EU product safety regulations
In December, the latest US and EU product safety regulations were released. Five major regulations on toy safety, thermal paper restrictions, and food and drug safety were all new.
Product regulation updates
1 American toy safety standard ASTM F963-16 released
On October 20, 2016, the American Association for Materials and Testing ASTM released the latest version of the “Consumer Safety Code - Toy Safety”: ASTM F963-16.
According to the Consumer Product Safety Improvement Act (CPSIA), if the US Consumer Safety Commission (CPSC) has no objection within 90 days, the new standard will become mandatory 180 days after publication (i.e. mid-2017). Certification (children's product certificate) for toys produced on or after the effective date must be tested in an ASTM F963-16 approved laboratory in accordance with ASTM F963-16 requirements.
Compared to the old standard, ASTM F963-16 removed state requirements in filler materials and revised test methods; revised requirements for sound toys, load and stability requirements for riding toys, and requirements for catapult toys; added requirements for expandable materials in toys — ASTM F963-16 4.40, design guidelines for toys with batteries, immersion tests for toys, requirements for toy cabinets, electric toy provisions; clarified microbial safety and new requirements, requirements related to heavy metals in toy substrates, and added an optional alternative test for total screening tests method.
The US toy safety standard ASTM F963 is essential for toys entering the US market. Toy companies are specifically reminded to pay close attention to the latest trends in standards and adjust countermeasures in a timely manner to avoid financial losses.
2 EU lowers BPA limit in toys
On November 14, 2016, at the EU Toy Safety Committee meeting, member states voted to pass the proposed limit adjustment for bisphenol A (BPA) in the toy safety directive proposed by the European Commission, mainly targeting BPA in children's toys under the age of three, to adjust the limit from 0.1 mg/L to 0.01 mg/L. The proposal will amend Annex II Appendix C of the EU Toy Safety Directive 2009/48/EC, and will be implemented 18 months after publication in the Official Journal of the European Union (OJ).
As the EU's strictest and most important toy standard safety directive, it stipulates mechanical and physical safety requirements, chemical requirements, flame retardant requirements, hygiene requirements, electrical safety, etc. that toys in the EU market must meet. The revision of the Toy Safety Directive will have a huge impact on toy manufacturers in China. Relevant enterprises need to pay attention to the revision of the Toy Safety Directive and prepare to respond.
3 REACH Regulation Annex XVII Officially Adds BPA Restrictions for Thermal Paper
On December 13, the Official Journal of the European Union (OJ) published (EU) 2016/2235. The restrictions on bisphenol A (BPA) were officially included in Annex XVII of the EU REACH regulation. Starting January 3, 2020, the limit of bisphenol A in thermal paper must not exceed 0.02%. (EU) 2016/2235 will take effect 20 days after OJ publication. Before the regulation is officially implemented on January 3, 2020, manufacturers and importers have 36 months to carry out rectification or other relevant preparations to meet the requirements.
Thermal paper is a type of processed paper. The manufacturing principle is to apply a layer of “heat-sensitive paint” (heat-sensitive color changing layer) composed of various chemicals, including BPA, to high-quality base paper, so that the paper can change color due to heat and show the characters to be displayed. The harmful effects of BPA are reflected in the effects on the female reproductive system, brain, behavior, mammary glands, metabolism, and obesity, with the most damaging effects on the mammary glands. The European Commission believes that if the BPA content in thermal paper exceeds 0.02%, there is an unacceptable adverse risk for workers who are regularly exposed to thermal paper.
4 EU Toy Safety Directive Heavy Metal Aluminum Migration Volume Will Be Reassessed
On November 28, 2016, at the request of the European Commission, the EU Scientific Committee on Health, Environment and Emerging Technology Risks (SCHEER) was required to provide its scientific opinion on the allowable intake of heavy aluminum in 2017 in order to revise the aluminum migration limits in toys accordingly.
SCHEER's next work will include the following two tasks:
- Review existing toxicological data on heavy aluminum, taking fully into account the relevant acceptable intake levels of the European Food Safety Authority EFSA in 2008 and JECFA in 2011;
- Give recommendations on allowable intake levels of heavy metal aluminum for use in setting aluminum migration limits in the Toy Safety Directive, requiring attention to sources of heavy metal aluminum other than toys
SCHEER is required to give initial comments in June next year and provide its final views in the fall.
5 FDA issues guidelines on the safety and effectiveness of sunscreen ingredients
On November 22, the US Food and Drug Administration (FDA) issued a guide to sunscreen products — “Non-prescription Sunscreen Drugs — Safety and Efficacy Data — Guidance for Industry” (Nonprescription Sunscreen Drugs — Safety and Efficacy Data — Guidance for Industry). This guide indicates the safe and effective standards for active ingredients in sunscreen products, and suggests that attention should be paid to the effects of active ingredients being absorbed into the bloodstream on the human body.
The FDA believes that manufacturers of over-the-counter sunscreens need to prove that the ingredients in the product are safe and effective, and that the safety of new sunscreen ingredients is a long-term issue. In the future, if brands and manufacturers want to use new ingredients in sunscreen products, they will need to apply for approval from the FDA. The data provided will include the degree of absorption of this component by blood, and this will be strictly managed using pharmaceutical standards.
Manufacturers should undertake extensive information components such as extracorporeal penetration tests of products, adverse drug experiences, and side effects. After the implementation of the new regulations, sunscreen product manufacturers have increased their testing ingredients, and the negative market opinion that it will bring to the safety of sunscreen products is also worrying. However, there is no doubt that stricter product testing regulations will eventually increase the safety and effectiveness of products. At present, our country has also begun to regulate sunscreen products, which are becoming more and more strict.
Safety and compliance tips
Product safety for curtains with drawstrings
Every year, October is American Curtain Safety Awareness Month. In the US, almost every month, a child dies from choking around their neck due to curtain pulls around their necks. The curtain cable problem has become one of the major safety risks for families. The drawstrings of roller blinds, blinds, and Roman curtains usually close to the bottom or side. If not fixed, the rope will slide down to form a ring that can easily be placed on the child's neck, causing the child to suffocate, and in severe cases, even death. However, many parents are still unaware of this problem, and curtain sellers have no corresponding reminders when selling. The US CPSC and the Curtain Safety Commission (WCSC) have agreed to promote the use of curtains without drawstrings or that are not easy to reach in homes, kindergartens, and other places for youth activities.
From time to time, we will bring you the latest product safety regulations and interpretations. We've also provided you with a number of third party service providers that provide product compliance solutions, click here to check them out.
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