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REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) is a chemical management regulation passed by the European Union in December 2006 based on the long-term consideration of protecting human health and environmental safety. The regulation came into force on June 1, 2007 and was implemented on June 1, 2008.
Under REACH regulations, all enterprises that produce or import more than 1 ton/year of chemical substances into the EU are required to register the chemical substances they produce or import with the European Chemical Administration.
Data update version date: 20161108
The Toxic Substance Control Act (TSCA) was officially implemented on October 11, 1976. It does not divide substances into toxic substances and non-toxic substances for management as the name suggests, but divides substances into existing chemical substances and new chemical substances for management. Existing chemical substances refer to those listed in the TSCA Inventory, which currently covers more than 83000 chemical substances. Manufacturers or importers of these substances need to regularly submit relevant information about the production, import and tonnage of substances to the U.S. Environmental Protection Agency, so that the U.S. Environmental Protection Agency can master the progress of business activities of enterprises.
Data update version date: 20161108
EN71 is the standard for toy products in EU market.
Children are the most concerned and cared for group in the whole society. The toy market that children generally love is developing rapidly. At the same time, various kinds of toys also cause harm to children due to various quality problems. Therefore, countries around the world are increasingly demanding toys on their own markets.
Many countries have established their own safety regulations for these products, and production companies must ensure that their products meet relevant standards before being sold in the region.
The manufacturer must be responsible for accidents caused by production defects, poor design or the use of inappropriate materials.
Therefore, the toy EN71 certification decree was introduced in Europe, which means that the toy products entering the European market will be technically regulated through the EN71 standard, so as to reduce or avoid the harm of toys to children.
Simulation test and judgment:
The leaching amount test (mg/kg) of the following eight metal elements harmful to children's growth and development in the raw materials used for toys with simulated gastric juice: antimony (6OPPM), arsenic (25PPM), barium (100OPPM), cadmium (75PPM), chromium (60PPM), lead (90PPM), mercury (60PPM), selenium (50OPPM)
The full series of EN71 standards: EN71-1~EN71-11 (11 parts currently applied); general toys, daily necessities, handicrafts, products similar to toys, baby products, etc. shall at least be subject to EN71-1- 2;- 3; The assessment of these three parts.
Data update version date: November 2016
ASTM F963 Standard Consumer Safety Specification for Toy Safety is the most important toy safety standard in the United States and has a great impact on the world. This specification was revised on June 12, 2012 to become a mandatory consumer toy safety standard specification, version number ASTM F963-11; The latest version was released on October 20, 2016, and the version number is ASTM F963-16. Only when this standard is met, can the product enter the American market.
This standard makes technical requirements and test methods for toys used by children under 14 years of age. This standard relates to the dangers that the public may not easily realize and that toys may encounter after normal use or reasonably foreseeable abuse. It only stipulates the safety performance of toy products and does not involve the performance and quality of toy products.
The main technical requirements of ASTM F963 include mechanical physical safety, combustion performance, chemical toxicity, electrical safety and microbial safety. The latest ASTM F963-16 includes the following new specifications and revisions in addition to the new standards on riding toys (please link to the website for details):
1. Label requirements for toys containing small coins and button batteries (new)
2. Requirements for lithium battery temperature and current limit (new)
3. Requirements for possible expansion of materials and toys in case of accidental ingestion (new)
4. The immersion and compression test of the reset magnet (revised)
5. New requirements and instructions related to microorganisms (revised)
6. Explain the requirements for key elements of toy matrix materials (revised)
7. Requirements for toys involving bullets (revised)
8. Supplementary guidance and requirements for describing impact hazards (revised)
In addition, from June 10, 2013, the CPSC required toy manufacturers to obtain third-party testing agency certification from CPSC certified laboratories to prove that their products meet the ASTM F963-11 Standard Consumer Safety Specification for Toy Safety
Data update version date: November 2016
Restriction of Hazardous Substances Directive
2002/95/EC (abbreviated as RoHS) is an environmental protection directive adopted by the European Union in February 2003. It is scheduled to enter into force on July 1, 2006. It mainly regulates the material and process standards of electronic products. The specification object of RoHS is the equipment with working voltage less than 1000VAC or 1500V DC, respectively: large household appliances, small household appliances, information technology and telecommunications equipment, consumer durable equipment, lighting equipment, motors and electronic tools, toys, leisure and sports equipment, medical machines, monitoring and control equipment, vending machines. The following six chemicals shall not be used in the manufacture of these products: lead (Pb), mercury (Hg), cadmium (Cd; the maximum allowable content is 0.01% (100ppm)), hexavalent chromium (CrV '), polybrominated biphenyl (PBB), polybrominated diphenyl ether (PBDE; the maximum allowable content is 0.1% (1000ppm))
On April 16, 2016, the Official Journal of Europe (OJ) issued (EU) 2016/585, updating the exemption items of Article 31a of Annex I IV of RoHS Directive 2 (Directive 2011/65/EU) on medical equipment and monitoring/control equipment. The new directive came into force on the 20th day of its promulgation and was officially implemented on November 6, 2017.
The Directive deleted the exemption in Article 31 and added the exemption in Article 31a. For the four harmful substances, lead, cadmium, hexavalent chromium and polybrominated diphenyl ether, it stipulated that medical equipment, in vitro diagnostic medical equipment, electron microscopes and their spare parts should be recycled and used for the maintenance and renovation of the above equipment.
Waiver Expires:
1. Spare parts for maintenance and refurbishment of medical equipment (excluding in vitro diagnostic medical equipment) – July 21, 2021
2. Spare parts for in vitro diagnostic medical equipment repair and refurbishment – July 21, 2023
3. Parts for electron microscope repair and refurbishment - July 21, 2024
Data update version date: November 2016
The Food and Drug Administration (FDA) is subordinate to the Department of Health, Education and Welfare of the United States. Its main function is to supervise and manage food, dietary supplements, drugs, vaccines, biopharmaceuticals, blood preparations, medical equipment, radioactive equipment, veterinary drugs and cosmetics produced and imported in the United States, At the same time, he is also responsible for implementing Article 361 of the Public Health Service Act, including the inspection of public health conditions and interstate travel and transportation, and the control of diseases that may exist in many products. FDA consists of the Drug Administration, the Food Administration, the Veterinary Drug Administration, the Radiation Health Administration, the Bureau of Biological Products, the Bureau of Medical Devices and Diagnostic Supplies, the National Toxicology Research Center, and regional work management agencies.
Data update version date: November 2016
The international Fragrance Association (IFRA) was founded in1973. IFRA has established specifications for spices and essence in products that contact human skin.
Research has found that when a variety of chemicals work together, they sometimes cause adverse reactions, especially for the human body. In order to ensure the safety of daily perfumes, IFRA invested and established RIFM (Research Institute FragranceMaterials) in 1966. RIFM cooperates with IFRA to formulate procedures, methods and plans for the safety evaluation of daily perfumes. The experts in the RIFM organization include chemists, biologists, toxicologists, etc., and have established cooperative relationships with relevant research institutes and universities to test and evaluate the safety of daily perfumes in batches. Every year, they will conduct experiments and Research on different chemicals in all fragrance containing products (such as perfume), and record their findings.
IFRA, based on the results of RIFM, puts forward the recommendations of prohibition and restriction (limiting the dosage, limiting the scope of use, or allowing the use when the purity reaches a certain level) in its "IFRA Code of Practice". In the past, IFRA has banned the use of some chemicals and essential oils that may cause adverse reactions to the human body. In June 2013, lFRA has officially notified to make the 47th revision of IFRA practice regulations as a part of the current safety plan of the industry. The safety plan of the spice industry aims to evaluate the spice raw materials and, based on the research on their possible impact on people and the environment, formulate "safe use" or prohibit their use. The safety plan currently contains 186 "standards" to restrict or prohibit the use of some spice ingredients.
Data update version date: 20161108
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