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Hazardous substance testing

Testing

Hazardous substance testing

RoHS testing
 
Overview
 
RoHS is a mandatory standard formulated by EU legislation. Its full name is the Directive on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment. The standard has been officially implemented since July 1, 2006, mainly used to regulate the material and process standards of electrical and electronic products, making it more conducive to human health and environmental protection. The purpose of this standard is to eliminate lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls and polybrominated diphenyl ethers in electrical and electronic products, and add 4 items of o-benzene, for a total of 10 substances.
 
Standards and Regulatory Requirements
 
EU Regulation/Directive: 2011/65/EU
2011/65/EU Hazardous Substances and Limit Requirements: The maximum allowable concentration of hazardous substances in homogeneous materials is:
 
 

restricted substances

maximum allowable concentration

lead

0.1 %

HG

0.1 %

cadmium

0.01 %

Hexavalent chromium

0.1 %

polybrominated biphenyls

0.1 %

Polybrominated diphenyl ethers

0.1 %

Di(2-ethylhexyl) phthalate

0,1 %

Tolyl butyl phthalate

0.1 %

Dibutyl phthalate

0.1 %

Diisobutyl phthalate

0.1 %

 

RoHS2.0
 
RoHS 2.0 (2011/65/EU) came into effect on July 21, 2011, and was officially implemented on January 3, 2013 (2002/95/EC was abolished on the same day), RoHS 2.0 expands the product range on the basis of the original RoHS directive To eleven categories, member states are required to ensure that the EEE and components including its repair parts or reuse or cables or upgrading its function/capacity are compliant with the new Directive. RoHS 2.0 gives a clear definition of homogeneous materials and stipulates the respective responsibilities and obligations of manufacturers, authorized representatives, importers, sellers, etc.; manufacturers must draft necessary technical documents during the production process, according to Article 768/ Model A specified in Annex II of Decision No. 2008/EC implements internal production control procedures, and also needs to provide a declaration of conformity, and the CE mark can be affixed to the end product after the product is qualified.
 
 
If the product does not contain toxic and harmful substances or elements, that is, all marked with "○", then the green environmental protection label is shown on the left as shown below; .
 
The second step is to implement strict supervision on the products that enter the "Key Management Catalogue for Pollution Control of Electronic Information Products". It is necessary to realize the substitution of toxic and harmful substances or meet the limit requirements, and then they can enter the market after compulsory certification (3C certification).
 
REACH
 
Overview
 
REACH regulation refers to the EU Regulation No. 1907/2006 on the registration, evaluation, authorization and restriction of chemicals, namely Registration, Evaluation, Authorisation and Restriction of Chemical. The REACH regulation is a mandatory regulation in the European Union for early warning management of all chemicals entering its market. It has built a huge chemical management system, requiring manufacturers, importers and downstream users of chemicals to be responsible for the safety of the chemicals used in their products to protect human health and the environment. The EU Chemicals Agency (ECHA) is fully responsible for the implementation of REACH regulations.
 
 
 
Standards and Regulatory Requirements
 
EU
REACH is the abbreviation of EU Regulations on Registration, Evaluation, Authorization and Restriction of Chemicals, which came into full effect on June 1, 2007. REACH replaces the current 40 EU regulations and becomes a unified set of management regulations for the registration, evaluation, authorization and restriction of chemicals.

Registration

The enterprise submits a dossier, detailing the various attributes of the chemical substances contained in the product, including use, safety control, risk responsibility, classification and labeling, etc.

Evaluation

The European Chemicals Agency (ECHA) conducts an assessment based on the registration dossier to realize the post-market supervision role of the regulations

Authorization
Some high-risk substances will be included in the authorization list. Before using these substances, an application for authorization must be submitted before they can be used.
Restriction
Incorporate more than 40 existing chemical laws into the management system, with more than 1,000 restricted substances
 
The REACH regulation divides the existence of substances into three categories: the substance itself, the substance in the mixture (Mixtures) and the substance in the article (Article). The REACH regulation has a complete registration and evaluation system, involving about 30,000 chemical substances, covering almost all products exported to the EU (except food, medicines and pesticides). In response to the SVHC requirements of REACH regulations, all links in the supply chain need to undertake corresponding obligations:
 
 
 
Substance Supplier > Submit SVHC Information —————————————————————> Recipient (Customer)
 
  SDS, test report
 
Preparation supplier > When SVHC ≧ 0.1%, submit SVHC name and concentration ——————> Receiver (customer)
 
                      SDS, test report, questionnaire
 
Parts supplier > When SVHC>0.1%, submit SVHC name and content——————> Recipient (customer)
 
Test report, survey form, item information sheet
 
 
 
End products - direct sales to Europe
 
SVHC Name —————————————————————> EU Consumer
 
When SVHC>0.1%
 
 
 
SVHC name and content ——————————————————> Notify ECHA
 
When the SVHC content of a single product is >0.1% and the content of all products is >1T/year
 
 
 
EU Importer - Indirect sales to Europe
 
SVHC Name —————————————————————> EU Consumer
 
When SVHC>0.1%
 
 
 
SVHC name and content ——————————————————> Notify ECHA
 
When the SVHC content of a single product is >0.1% and the content of all products is >1T/year
 
Relevant requirements for the export of end products to EU countries:
Substances of Very High Concern SVHC (Substances of Very High Concern) Up to now, a total of 169 SVHC candidate substances have been listed.
 
 
   China
 
 
   The "Measures for Environmental Management of New Chemical Substances" was promulgated by the Ministry of Environmental Protection of China and came into force on October 15, 2010.
Producers or importers of new chemical substances must report before production or import, and obtain a new chemical substance environmental management registration certificate (hereinafter referred to as the "registration certificate"). The production, import and processing of new chemical substances that have not obtained a registration certificate are prohibited. New chemical substances that have not obtained a registration certificate or have not been filed and declared shall not be used for scientific research.
New chemical substances are required to complete declaration and registration before import or production, including scientific research filing declaration, simple declaration and routine declaration; the declaration materials may include new test items and chemical safety reports.
According to the identification and classification standards of chemical hazard characteristics, new chemical substances are divided into general new chemical substances and dangerous new chemical substances. Among the hazardous new chemical substances, the chemical substances with the characteristics of persistence, bioaccumulation, ecological environment and human health hazards are listed as key environmental management hazardous new chemical substances.
 
 
  Japan
 
  "Law on the Inspection and Manufacture of Chemical Substances, etc." (referred to as "Chemical Inspection Law").
 
 
  Introduction to regulations
 
    The Japan Chemical Review Law was officially promulgated in 1973 by the Ministry of Economy, Trade and Industry (METI), the Ministry of Health, Labour and Welfare (MHLW), and the Ministry of the Environment (MOE).
    In 2009, the revised Japanese Chemical Review Law was officially released to assist Japan in achieving the goal of sound management of chemicals in the United Nations SAICM in 2020. The Chemical Review Law passed the inter-departmental cooperation of the three provinces, aiming to prevent the environmental pollution caused by chemicals from potentially affecting human health. The specific hazards of the new chemical should be assessed as a priority before the chemical is manufactured or imported for industrial use. The changes in the revised Japanese chemical review law are mainly reflected in the CSCL’s transformation into a risk-based chemical management regulation, the introduction of an integrated management system covering existing chemical substances in the regulation, and the provision of requirements, evaluation and management for rationally regulated chemical substances in the supply chain. Rationalization of the framework and requirements to communicate chemical information to relevant authorities, etc.
 
 
CPSIA
 
1 Overview
 
The US Consumer Product Safety Improvement Act of 2008 officially became law in August 2008 (Public Law Number: 110-314). The law is said to be the toughest consumer protection law since the establishment of the Consumer Product Safety Commission (CPSC) in 1972. In addition to imposing stricter lead content limits on children's products, it also imposes restrictions on three types of harmful neighbors in toys and child care products. Phthalates (di-2-ethylhexyl phthalate DEHP, dibutyl phthalate DBP, butyl benzyl phthalate BBP) imposed permanent restrictions on three other phthalates Formates (diisononyl phthalate DINP, diisodecyl phthalate DIDP, dioctyl phthalate DNOP) are subject to a transitional period order. In addition, the regulation increases the CPSC's budget and expands its enforcement powers, including protecting whistleblowers and requiring third-party testing of certain children's products before they are marketed.
 
 
2. Limitation of lead content in non-surface coating materials for children's products:
 
 
Limit lead content in parts of children's products. The requirement will be implemented in stages, with the ultimate goal of reducing the limit on the total lead content of any accessible part of the product to no more than 0.01% by weight (100 ppm). The regulation also requires CPSC to periodically review this requirement and make necessary modifications (lower limits).
 
1. Limits of lead content (total lead content by weight):
 
* 0.06% (600 ppm), 180 days after the regulation takes effect (February 10, 2009);
 
* 0.03% (300 ppm), the regulation will be implemented after 1 year (August 14, 2009);
 
* 0.01% (100 ppm), 3 years after the regulation takes effect (August 14, 2011);
 
 
2. Hazardous Substance Exposure:
 
*The above limits do not apply to parts of children's products that are not accessible to children under reasonably foreseeable use or abuse;
 
* Within one year of the regulations taking effect (before August 14, 2009), the CPSC should publish rules that provide guidance on which product parts are considered inaccessible;
 
* Paints, coatings or electroplatings cannot be considered as a barrier to children from the underlying lead;
 
* The CPSC should study to determine whether electronic equipment and batteries need to fully comply with the limit requirements.
 
 
There are stricter restrictions on lead paint:
 
The lead content limit in lead paint (16 CFR 1303.1) was reduced from 0.06% to 0.009%, effective 1 year after the regulation went into effect (August 14, 2009).
 
 
Product Safety Certification:
 
1. General Certificate of Conformity
 
Beginning 90 days after the regulations take effect (November 12, 2008), U.S. importers and U.S. manufacturers of regulated products are required to provide certificates that their products meet the requirements of relevant applicable standards and regulations. Controlled products include all products regulated under the Consumer Product Safety Act and all other similar guidelines, prohibitions, standards or regulations administered by the CPSC.
 
 
PAHs
 
1 Overview
 
Polycyclic Aromatic Hydrocarbons (PAHs) refers to a class of organic compounds with two or more benzene rings. PAHs are hydrocarbons containing more than two benzene rings in the molecule, including more than 150 compounds such as naphthalene, anthracene, phenanthrene, and pyrene.
 
 
2. Standards and regulatory requirements
 
So far, countries and regions have determined through written laws or decrees:
EU: REACH Annex 17;
Germany: GS certification
 
REACH Annex 17 Article 50 involves 8 PAHs: Benzo(a)pyrene (BaP), Benzo(b)pyrene (BeP), Benzoanthracene (BaA), Chrysanthemum (CHR), Benzo(b)fluorine Anthracene (BbFA), Benzo(j)fluoranthene (BjFA), Benzo(k)fluoranthene (BkFA), Dibenzoanthracene (DBAhA). It is stipulated that the total mass fraction of 8 PAHs in the tire filler oil is ≤0.001%, of which the mass fraction of BaP is ≤0.0001%.
 
In the GS certification, the ZEK 01.4-08 standard is used to detect the 18 PAHs involved, and the substances involved are as follows:
On August 4, 2014, the German Technical Equipment and Consumer Products Committee (ATAV) announced new control requirements for polycyclic aromatic hydrocarbons (PAHs) that require GS certification, and the effective date is July 1, 2015.
 
Table 1: Restriction requirements for PAH in the new standard (unit: mg/kg)。
 
 
 

substance

Category 1

Category 2

Category 3

Materials that are placed in the mouth, or toy materials that are in prolonged contact with the skin (more than 30 seconds)

Materials not included in Category 1 with prolonged skin contact (more than 30 seconds), or repeated short-term skin contact

Materials not covered by categories 1 and 2, with short-term skin contact (not more than 30 seconds)

2009/48/EC
range of toys

Other products

2009/48/EC
range of toys

Other products


Benzo(a)pyrene

< 0.2

< 0.2

< 0.5

< 0.5

< 1

Benzo(e)pyrene

< 0.2

< 0.2

< 0.5

< 0.5

< 1


Benzo(a)anthracene

< 0.2

< 0.2

< 0.5

< 0.5

< 1


Benzo(b)fluoranthene

< 0.2

< 0.2

< 0.5

< 0.5

< 1

Benzo(j)fluoranthene

< 0.2

< 0.2

< 0.5

< 0.5

< 1

Benzo(k)fluoranthene

< 0.2

< 0.2

< 0.5

< 0.5

< 1


bend

< 0.2

< 0.2

< 0.5

< 0.5

< 1

Dibenzo(a,h)anthracene

< 0.2

< 0.2

< 0.5

< 0.5

< 1


Benzo(g,h,i)perylene

< 0.2

< 0.2

< 0.5

< 0.5

< 1

Indenebenzene(1,2,3-cd)pyrene

< 0.2

< 0.2

< 0.5

< 0.5

< 1

acenaphthene, acenaphthene, fluorene
phenanthrene, pyrene, anthracene
Fluoranthene

<1
 

< 5

< 10

< 20

< 50

Naphthalene

< 1

< 2

< 10

18 total PAHs

< 1

< 5

< 10

< 20

< 50

 

California 65
 
Overview
 
California Proposition 65, the Drinking Water Safety and Toxic Substances Enforcement Act of 1986, was issued in November 1986 to protect California residents and the state's drinking water sources from sources known to cause cancer, Birth defects or other reproductive and developmental hazard substances, and truthfully notify residents when such substances appear in products. The California 65 Controlled Substances List is published by OEHHA and updated quarterly and was first published in 1987. Products sold in California must comply with California Statute 65.
 
 
 
The list is updated at least annually;
More than 960 chemical substances are currently on the substance list.
 
 
Which consumer products have experienced litigation?
 
Litigation against manufacturers and retailers spans a wide range of consumer products, including:
 
• earphone
• camera
• Audio
• Toy
• Ceramic tableware
• Crystal products
• Correction fluid
• Outdoor decorative glass products
• Textiles
 
• Jewelry
• Lead fishing tackle
• Nail polish
• Dental fillings
• PVC computer peripherals
• PVC electrical tape
• PVC fiber optic cable
• PVC lunch box
• paint
 
Limit standard
 
California 65 controls and assesses whether a specific product contains toxic substances based on court cases of similar products. It is not recommended to test more than 960 chemicals on the list for one product, because it is almost impossible for a product to contain all the chemicals on the list. The types and limit requirements of chemical substances controlled by specific products need to be based on the latest judgments of similar product cases. For example, after a company is sued for containing lead in a certain part of the product and loses the lawsuit, a limit will be announced in the court, then this limit It will be used as the limit of lead content in the parts of this type of products in the future.
 
For different products, different materials, different chemical substances under control, the limit requirements are also different.
 
Some of the case requirements for California Proposition 65 are listed in the table below.
 
 

project

Cover products

substance

Limit requirements

1

Toys and Child Care Products

lead

Paint and coating materials≤90ppm
PVC material, baby bib≤200ppm
Other materials≤600ppm

邻苯

DEHP, DBP,BBP,DIDP和DnHP respectively less than 0.1%

2

children's jewelry

cadmium

≤300ppm

3

 

fashion accessories
 
(Clothing such as gloves and hats, bag accessories and zippers, belts, cosmetic bags, luggage and ID bags, covers for magazines or address books, covers for mobile electronic devices, glasses cases, footwear, handbags, wallets, coins Wallets, Wallets, Jewelry, Keychain Chains,)

lead

Paint and coating materials≤90ppm
Leather≤300ppm
PVC material≤200ppm
Other materials≤300ppm

Phthalic

DEHP, DBP,BBP respectively less than 0.1%

4

headphone cable

Phthalic

BBP, DBP, DEHP,DIDP,
DINP,DNHP 
respectively less than 0.01%

 

Phthalates
 
Overview
 
Phthalates, also known as phthalates, abbreviated PAE, are the general term for esters formed by phthalic acid. Phthalates are a class of softening chemicals that are commonly used as plasticizers in toys, food packaging, vinyl floors, wallpapers, cleaners, nail polishes, sprays, shampoos, and body washes, etc. among hundreds of products. Studies have shown that phthalates can interfere with endocrine, reducing the number of male sperm, low motility, abnormal morphology, and in severe cases, still spermatozoa and testicular cancer, which are the "culprit" of male reproductive problems.
 
 
 
Standards and Regulatory Requirements
 
On December 14, 2005, the European Parliament and the Council promulgated the Phthalates Directive (2005/84/EC), which was later replaced by 552/2009/EC, and is currently Annex 17 of the REACH Regulation, which requires children's toys , The content of DEHP, DBP and BBP in plastic materials in children's care products is less than 1000ppm; the content of DINP, DIDP and DNOP in plastic materials that children can put in is less than 1000ppm. All the above products shall not be placed on the market if they do not meet the limit requirements.
 
Following 2005/84/EC, all countries have formulated laws and regulations to control related phthalates in toys. In 2007, California promulgated AB 1108 to control ortho-6P in toys. No one is allowed to produce or sell the following products: children's toys or child care products with DEHP, DBP, BBP concentrations exceeding 0.1%; any containing DINP, DIDP, DNOP Children's toys or child care products intended for use by children under 3 years of age that can be placed in the mouth in concentrations exceeding 0.1%. The 2008 U.S. Consumer Product Safety Improvement Act (CPSIA) controls ophthalmic 6P in toys, which stipulates that after the decree takes effect 180 days (February 10, 2009), it will be considered illegal to provide the following products: Any containing DEHP, DBP, BBP Children's toys or child care products with a concentration of more than 0.1%; any children's toys or child care products containing DINP, DIDP, DNOP in a concentration of more than 0.1% that can be placed in the mouth.
China, GB 24613-2009 "Limits of Hazardous Substances in Coatings for Toys" requires that the total concentration of phthalates DEHP, DBP and BBP in toy coatings is less than 0.1%; the total concentration of DINP, DIDP, DNOP does not exceed 0.1%.
 
Japan, Canada and other countries have also successively formulated control requirements for phthalates in toys.、
 
 

REACH Annex17
((EC) No 552/2009)

DEHP, DBP, BBP; DINP, DIDP, DNOP(Toys, Children's Products

CPSIA (HR 4040)

DEHP, DBP, BBP; DINP, DIDP, DNOP(Children's toys, child care products

加州 AB 1108

DEHP, DBP, BBP, DINP, DIDP, DNOP (Children's toys, child care products)

Proposition 65

DEHP, DBP, BBP, DIDP, DNHP,DINP

丹麦

DEHP、DBP、BBP、DIBP(Accessible Indoor Products

SVHC

DEHP, DBP, BBP, DIBP, DIHP, DHNUP, DMEP, DIPP; n-Amylisoamyl phthalate; branched and straight-chain 1,2-benzenedicarboxydipentyl ester