Can materials be combined into one group to perform chemical testing?
It depends on the test requirement and test method. Depending on the specific test criteria, if the test limit is very low, combining materials to perform the test is not advisable, as the dilution of the specimens may affect the results. Additionally,
certain test methods do not allow for this practice. As a general practice, third party labs may combine three "similar" materials (same category) into one group to perform a test. For example, three plastic materials, three textile materials,
three wooden materials, etc. may be combined. For some specific materials (metal, ceramic, glass, etc.), combining more than one material to perform the test is not acceptable due to the characteristics of the material.
The only difference in a series of products is the color; why does each one have to be tested?
A different color means different chemical pigments/colorants in the product. Some of the pigments/colorants may contain hazardous substances; therefore, each one needs to be tested to ensure product compliance to applicable chemical testing requirements.
Why is a QIMA test report necessary?
QIMA is an independent ISO 17025 accredited third party testing laboratory. QIMA has received accreditation by different bodies such as ANAB (US), CNAS (China), HOKLAS (HK) and UKAS (UK). It is an accepted testing institute by the US Consumer
Product Safety Commission (CPSC) to perform third party testing to assess conformity to children's product safety regulations in the United States.
Test reports issued by QIMA help to ensure product compliance according to the requirements of the country of destination or specific end customers. For countries like the United States that require mandatory third party testing on children's
products, the manufacturer or importer can also issue the Children's Product Certificate (CPC) to certify its children's product compliance based on the compliance results identified in the QIMA test reports.
What is a Fabric Mask?
Fabric mask is a non-medical device, cloth face covering and loose fitting. It only intends to help contain the wearer’s respiratory droplets from spreading. Fabric mask provides a relatively low level of protection.
What is a Medical Face Mask?
Medical mask, also called a surgical mask, is usually flat or pleated and is disposable. The mask creates a protective barrier to prevent splashes, sprays, large droplets, or splatter spreading from and entering into the wearer’s mouth and/or nose.
It provides medium level of protection.
What is a Respirator Mask?
- A respiratory protective device designed for a very close facial fit with an outer edge, designed to seal around the nose and
- Provides efficient filtration against inhaling hazardous airborne particles, gases and vapors
Provides a relatively high level of protection
What are the performance metrics for a face mask ?
a. BPE- Bacterial Filtration Efficiency
The effectiveness of the face mask material in preventing the passage of aerosolized bacteria. It is the measure of the efficiency of the mask in filtering bacteria passing through it.
- Particle Filtration Efficiency
The efficiency of the filter material in capturing aerosolized particles smaller than one micron. It is the measure of the efficiency of the mask in filtering particles passing through it.
to Penetration by Synthetic Blood / Fluid Resistance
The ability of the filter material to resist fluid penetration. It is the measure of the material construction of the mask's ability to minimize fluids passing through it.
The pressure drop across the mask material. It is the measure of breathing resistance of a mask (the higher the value, the less the breathability, but the better the filtration).
e. Flammability/Flame Spread
subjection of the face mask material to a flame. The measurement rate at which the material burns determines the level of flammability and any related hazard.
For certain tests, why does it take so long to complete the test? (for example, nickel release testing for Europe)
The time needed to complete the testing depends on factors such as sample preparation and test method. For example, in accordance with the European requirement EN 1811 for nickel release, the test method requires the test specimen to be immersed in
the test solution for (168±2) hours. In addition, instrumentation analysis must be completed and time is needed for sample preparation, report typing, report approval/signature, etc.
In the European Union (EU), what is the difference between the Waste Electrical and Electronic Equipment requirement (WEEE) and the Battery Directive
WEEE is applicable to all electrical and electronic equipment regardless of whether the battery is included/provided or not. The symbol below (with a black bar under the wheelie bin) must be marked on the product. It is optional to include the mark
on the packaging.
For the battery directive, it is applicable to batteries. The symbol below (without
a black bar) shall be marked on the battery itself whenever possible. If the size of the battery is too small, the symbol can be marked on the packaging.
This symbol must cover:
At least 3% of the surface area on the largest side of a non-cylindrical battery or battery pack, or at least 1.5% of the total surface area on a cylindrical battery. In either case, up to a maximum size of 5cm x 5cm
If a battery is so small that the size of the symbol would be less than 0.5cm x 0.5cm, then you must place the symbol on the packaging, but it must be at least 1cm x 1cm.
Chemical symbols - batteries, accumulators and button cells containing more than 0.0005 % mercury shall be marked with the chemical symbol for the metal concerned: (Hg) (Peg) Is Mercury the only one with this requirement or should this state:
"Chemical symbols (Hg20, Cd, Pb) should be marked on batteries, accumulators and button cells which contain more than a given amount of these metals (0.0005% mercury, 0.002% cadmium and 0. 004% lead).
Any chemical symbols required must:
- be directly below the crossed out wheeled bin symbol and
- cover an area of at least 25% of the crossed out wheeled bin symbol
What is LVD testing for the European market?
The Low Voltage Directive (LVD) outlines essential safety requirements for electrical equipment operating with a voltage of between 50 V and 1000 V for alternating current and 75V and 1500V for direct current.
It is comprised of 11 safety objectives and addresses risks from using electrical equipment, including electrical, mechanical and chemical hazards (e.g., emission of aggressive substances). It also covers health risks associated with noise, vibration
and ergonomic factors
It applies to a wide range of electrical equipment for both consumer and professional usage, such as:
- Household Electrical Appliances
- Lighting equipment
- Power supply units
- Laser equipment
- Certain components (e.g. fuses)
European Union (EU) legislation in the electrical sector is important because it ensures health and safety requirements are the same across Europe for products that are placed in the market.
What is EMC testing for the European market?
All electric devices or installations influence each other when they are interconnected or placed closely with each other, e.g. interference between TV sets, global system for mobile communications (GSM) handsets, radios and nearby appliances
(e.g., washing machine) or electrical power lines. The purpose of electromagnetic compatibility (EMC) is to keep all those side effects under reasonable control. EMC designates all the existing and future techniques and technologies for reducing
disturbance and enhancing immunity.
The EMC Directive 2014/30/EU ensures that electrical and electronic equipment does not generate, or is not affected by, electromagnetic disturbance.
The EMC directive limits electromagnetic emissions from equipment in order to ensure that, when used as intended, such equipment does not disturb radio, telecommunication and other equipment. The directive also governs the immunity of such equipment
to interference and seeks to ensure that the equipment is not disturbed by radio emissions when used as intended.
The main objectives of the directive are to regulate the compatibility of equipment regarding EMC:
- equipment (apparatus and fixed installations) needs to comply with EMC requirements when it is placed on the market and/or taken into service
- the application of good engineering practice is required for fixed installations, with the possibility that competent authorities of EU countries may impose measures in instances of non-compliance
What is RED testing for the European market?
The Radio Equipment Directive 2014/53/EU (RED) covers electrical or electronic products which intentionally emit and/or receive radio waves for the purpose of radio communication and/or radiodetermination, or products that, when completed with
an accessory such as an antenna, meet the description.
The essential requirements of the RED are:
- Protection of health and safety of the user and any other person
- Electromagnetic Compatibility (EMC)
- Effective use of the radio spectrum to avoid harmful interference
Should we regard rainbow coating effects in any directions as gradient or uniform sunglasses？How is the uniformity evaluated within the lens in Europe according to ISO 12312:2013+ A1:2015 Eye and face protection — Sunglasses and related eyewear clause
5.3.1, or in the US according to ANSI Z80.3:2018 Nonpresciption Sunglass and Fashion Eyewear Requirements - Sections 4.11.3 & 4.11.4？
According to ISO 4007:2018 Personal protective equipment - Eye and face protection - Vocabulary clauses 126.96.36.199, 188.8.131.52 and 184.108.40.206 quoted below, the above examples of lenses are considered to be gradient filter.
Filter (220.127.116.11) with a defined transmittance(18.104.22.168) and/or color change within the full size of the filter (generally in the vertical direction)
Linear gradient-tinted filter
Gradient-tinted filter (22.214.171.124) in which the change in transmittance (126.96.36.199) or color is in a single linear direction
Radial gradient-tinted filter
Gradient-tinted filter (188.8.131.52) in which the change in transmittance (184.108.40.206) or color radiates from a single point, usually the reference point of the filter (220.127.116.11)
Is there any UV400 requirement within ISO12312-1:2013+A1:2015 Eye and face protection — Sunglasses and related eyewear?
No. The UV requirement in ISO 12312-1 covers the range of 280nm to 380nm. If you require UV400 protection, recommend to extend the range of “280nm-380nm” to “280nm-400nm”, with acceptance criteria referred to as UV 280nm-380nm.
Is it possible to not test the polarized function if “polarized” or related wording is marked on the sunglasses ?
Marked = Claimed
Therefore, as a claim, the transmittance requirement of polarization function must be tested.
Are the measuring conditions of regular sunglare filters and polarized filters the same ?
No. Luminous transmittance is measured under a regular light beam source, whereas polarized filters are measured with plane polarized light using linear polarizers in a spectrophotometer with polarization efficiency over 97.5%.
Is Blue light filtering equivalent to Blue signal light?
"Blue signal light" is one of “the relative visual attenuation quotient Q of filters” in the “Driving and Road Use” section in the standard. It should be tested together with yellow signal light, red signal light and green
signal light to see if the lens will have any effect/color difference when looking at the signal light. Traffic signal light testing range is the same as Luminous Transmittance range between 380nm-780nm. This is not the same as a blue
light filtering function. Signal light detection is a mandatory item for fashion sunglasses testing.
"Blue light filtering" is a lens filtering function of blue light from natural light source, test spectrum between the range 380nm-500nm. It is a claimed item, not manadatory. If the lens is claimed to have blue light filtering,
apart from the mandatory test items, the blue light transmittance shall be tested to determine the percentage of blue light transmission by sunglass filters.
If the lens is failed in "Blue signal light" for driving use, client should have warning statement to ensure people cannot use it for driving. However, it is not related to blue light filtering function. If "Blue light filtering" is fail, client
cannot claims the sunglasses to have "Blue Light Blocking %" or "Blue light Transmittance %".
Blue light transmittance vs Blue light blocking (Absorption)
If the lenses are claimed to have Blue light filtering function, we can measure the blue light transmittance or blue light blocking. The testing range is a selected range between 380nm-500nm.
If the claime for blue light blocking is 35%,
it can be presented in 2 ways :
a.. Blue light absorption = 35%. ; or
b.. Blue light transmittance = 65%
Is it required for brands to have certificate for spectacle frames or sunglasses when distributing in the European Community ?
Spectacle frames or fashion sunglasses are required to have the following documents to import into EU countries.
Before marketing (launch to the market for sales and service) the device, the manufacturer/European representative/the distributor should provide:
1. Technical file: which consists of:
- Product Drawing + Material List
- Test Report – proving applicable testing of the products has been conducted in accordance with the technical standards to verify the compliance of the device with the ESSENTIAL requirements
2. Quality plan - Monitoring the quality of products
3. Declaration of Conformity - stating the device complies with the provision of (EU) 2017/745 – Medical Device Regulations for spectacle frames and (EU) 2016/645 - Personal Protective Equipment Regulation – for fashion sunglasses
4. CE MARK: an affixed CE mark on the device if quality of products are meeting the requirements set by European markets.
In European countries, the manufacturer is allowed to provide a self declaration. Tests can be performed by a third party laboratory or by an in-house laboratory depending on the buyers / wholesalers' preference.
Would it be appropriate to claim a 100% blue blocking rate between 410nm and 480nm/500nm?
100% bluelight blocking would cause a significant color deviation and potentially interfere with driving or cause eye strain.
The below diagram shows the visual color change with different levels of blue light blocking (low blocking percentage
on the left, higher blocking on the right).
For food contact materials, is European Union (EU) testing necessary if country specific tests have already been completed, such as those outlined in the Food and Commodities Act for Germany (LFGB) or in the French General Directorate for Competition
Policy, Consumer Affairs, and Fraud Control for France (DGCCRF)? Is REACH testing necessary if FCM tests have been completed already?
Yes, even if compliance has been confirmed through testing in accordance with LFGB/DGCCRF, materials/products must also comply with the EU food contact regulation. Additionally, it should be noted that apart from EU food contact tests, there are additional
requirements in LFGB/DGCCRF. Therefore, testing for these country requirements must also be addressed based on country of distribution.
REACH requirements are different from FCM requirements. Therefore, for food contact materials, both
REACH and FCM tests are applicable.
Can bamboo be used as an additive for plastic food contact materials in the EU?
No. According to Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food, only the substances included in the Union list of authorised substances set out in Annex I may be intentionally used in the manufacture
of plastic. Bamboo is not on a list of authorised substances; hence, there is "no legal basis" that exists for the use of bamboo flour as an additive in plastics in the EU.
“Wood flour and fibers, untreated” are authorised substances under FCM substance No. 96 in Annex I to Regulation (EU) No. 10/2011. Will this make “bamboo” become a legal additive for plastic food contact materials?
No. According to the opinion from the European Food Safety Authority (EFSA), the safety of wood should be evaluated on a case by case basis, given the chemical differences in composition of wood species. This opinion does not support the authorization
of “wood flour and fibers, untreated” being applied to additives derived from the grass family like bamboo flour or similar substances, especially when there are no other substances in Annex I to Regulation (EU) No. 10/2011 which cover the use
What are the essential toys safety requirements in Europe?
The European Community (EC) Toy Safety Directive (2009/48/EC) identifies the safety criteria that toys must meet before being marketed in Europe. The essential safety requirements cover both general risks and particular risks. Toys must not pose general
risks which would adversely affect the safety or health of users or third parties when used as intended or in a foreseeable way, bearing in mind the behaviour of children. The ability of the user or supervisor is taken into account, particularly
for toys intended for children under 36 months. Toys must not pose particular risks such as hazards relating to physical/mechanical properties, flammability, electrical properties, hygiene requirements, radioactivity and chemical properties.
The particular safety requirements addressing particular hazards are set out in Annex II of Directive on the Safety of Toy Safety Directive (2009/48/EC). Toys which conform to the relevant harmonised standards that were published in the Official
Journal of the European Union are presumed to conform to the essential safety requirements. All toys sold in the EU must carry a marking which is the manufacturer's declaration that the toy meets the essential safety requirements.
What type of information should be included on the packaging of a toy product to meet the United States (US) and European Union (EU) labeling requirements?
US Toy Labeling Requirements
1. Consumer Product Safety Improvement Act (CPSIA) tracking label requirement which includes:
- Manufacturer or private labeler name;
- Location and date of production of the product;
- Detailed information on the manufacturing process, such as a batch or run number, or other identifying characteristics; and
-Any other information to facilitate ascertaining the specific source of the product
2. Uniform Packaging and Labeling Act (UPLA) requirement which includes:
- the identity of the commodity;
- the name and place of business of the manufacturer, packer, or distributor; and
- the net quantity of contents in terms of weight or mass measure, or numerical count in a uniform location upon the principal display panel
3. Country of Origin
4. ASTM F963 Warning Statements, based on the product age grade and features, as applicable
European Toy Labeling Requirements
- Name and address of manufacturer / authorized representative / importer into the community / distributor
- Type, batch, serial or model number
- Washing instructions for textile toys intended for use by children under 36 months (if applicable)
- EN71-1 Warning Statements, based on the product age grade and features, as applicable
- CE marking
* Warning and safety statements/instructions shall be written in the primary languages understood by consumers of the country in which the toy is to be sold
What steps are followed if attachments are non-graspable when testing in accordance with the BS 7907 Code of Practice for the Design and Manufacture of Children's Clothing to Promote Mechanical Safety (British Standard)?
Some attachments on garments may be non grippable like sequins, beads, stones, decorative bows, small pompoms, etc. If such non grippable items are attached to a garment, either functional or decorative, this garment should be subjected to a washing
method rather than a testing method to determine removal force, as per below processing.
The garment should be washed in a temperature of 10ᵒC±2ᵒC above the maximum recommended wash temperature. For hand wash only, 40ᵒC±2ᵒC should be used. The washing criteria, detergent, and drying technique should be performed as specified in BS
7907, ANNEX C.
Is there any information that should be included on transparent (poly) bag packaging for products distributed in the US?
There are no federal laws which require warning labels on plastic (poly) bags. However, some states and a few municipalities have enacted their own legislation with regard to suffocation warning labels for plastic (poly) bags.
For example, plastic (poly) bags in California, Massachusetts, New York, Rhode Island, and Virginia require the following warning:
"WARNING: To avoid danger of suffocation, keep this plastic bag away from babies and children. Do not use this bag in cribs, beds, carriages or play pens. This bag is not a toy."
Note: The requirements vary from state-to-state, based on criteria such as thickness of (poly) bag, dimensions and opening size of (poly) bag, and intended use of (poly) bag. Additionally, the warning labeling type size and placement may vary.
What is FCC testing for the United States?
Federal Communications Commission (FCC) regulates interstate and international communications by radio, television, wire, satellite and cable in all 50 states, the District of Columbia and U.S. territories. Radio Frequency (RF) devices are required
to be properly authorized under 47 CFR part 2 prior to being marketed or imported into the United States. The Office of Engineering and Technology (OET) administers the equipment authorization program under authority delegated to it by the
Commission. This program is one of the principal ways for the Commission to ensure that RF devices used in the United States operate effectively without causing harmful interference and that they otherwise comply with the Commission's rules.
All RF devices subject to equipment authorization must comply with the Commission's technical requirements prior to importation or marketing.
Equipment that contains an RF device must be authorized in accordance with the appropriate procedures specified in 47 CFR part 2, subpart J (with certain limited exceptions). These requirements not only minimize the potential for harmful
interference, but also ensure that the equipment complies with the rules that address other policy objectives, such as human RF exposure limits and hearing aid compatibility (HAC) with wireless handsets.
The Commission has two different approval procedures for equipment authorization:
2. Supplier’s Declaration of Conformity (SDoC)
The required procedure depends on the type of equipment being authorized as specified in the applicable rule part. In some instances, a device may have different functions resulting in the device being subjected to more than one type of approval
Why are so many samples required for certain Food Contact Material (FCM) tests?
The sample size required may depend on factors such as sample preparation and test method. For example, in the US, the food contact test method for extracting lead and cadmium from glazed ceramic surfaces as specified in ASTM C738, requires six identical
units for testing. In order to ensure timeliness of test results, for some tests, QIMA may request a few additional samples when confirmation testing is necessary.
What care label regulations are required in the US market?
Care labels for textile articles in the US market must comply with the mandatory 16 CFR 423, Care Labeling of Textile Wearing Apparel and Certain Piece Goods as Amended, regulation. Additionally, the two industry standards, ASTM D5489, Standard Guide
for Care Symbols for Care Instructions on Textile Products, and ASTM D3938, Standard Guide for Determining or Confirming Care Instructions for Apparel and Other Textile Products, should be met.
What fabrics and softlines products intended for adults are exempt from flammability testing per US regulations?
The following fabrics and products for adults are exempt from flammability testing:
-As per the Code of Federal Regulations (CFR), Standard for the Flammability of Clothing Textiles, 16 CFR 1610.1 (d), plain surface fabrics, regardless of fiber content, weighing 2.6 ounces per square yard or more
-All fabrics, both plain surface and raised-fiber surface textiles, regardless of weight, made entirely from any of the following fibers or entirely from a combination of the following fibers: acrylic, modacrylic, nylon, olefin, polyester, wool
-Hats, if they do not cover face, neck and shoulder
-Gloves, if they are not longer than 14 inches or attached in the garment
-Handkerchiefs, under 24 inches on any side (handkerchiefs are not exempt if attached with garment)
-Interlining (if used only for this purpose)
-Veils, not longer than 9 inches from crown; not longer than 2 inches from the edge of the brim
What bacteria should be used when performing testing in accordance with American Association of Textile Chemists and Colorists, AATCC 100?
In general, the AATCC does not define the bacteria that should be used to perform the testing outlined. AATCC 100 is a quantitative assessment of Antibacterial Finishes on Textile Materials. Following laboratory practice, if the client has
a testing manual or protocol, this would be referenced to follow any specific bacteria that should be applied. However, if this criteria is not defined, laboratory practice would be to use Staphylococcus aureus (ATCC 6538) & Klebsiella
pneumoniae (ATCC 4352).
In addition, if the textile article includes durability claims, the laboratory will address client requirements relative to testing on original "as received" samples or on washed samples, as directed. Furthermore, if testing is to be performed
on washed samples, additional parameters must be addressed such as the number of wash cycles and any actual care instructions included with the textile article.
What are the performance levels of a Medical Face Mask?
From ASTM F2100 - Standard Specification for Performance of Materials Used in Medical Face Masks
||Level 3 Barrier
|Bacterial filtration efficiency (BFE), %
|Differential pressure, mm H2O/cm2
|Sub-micron particulate filtration efficiency at 0.1 micron (PFE), %
|Resistance to penetration by synthetic blood, (mmHg)
Class 1 means the material exhibits normal flammability and is acceptable for use in clothing
What is toy safety standard in the US?
Toy safety standard in the US refers to ASTM F963-17, the Standard Consumer Safety Specification for Toy Safety. This standard, as incorporated with a modification shown in 16 CFR Part 1250, is a comprehensive standard addressing numerous hazards
that have been identified with toys. In 2008, the Consumer Product Safety Improvement Act of 2008 (CPSIA) mandated that the voluntary toy safety standard in effect at that time (ASTM F963) become a nationwide mandatory children's product safety
All toys designed or intended for use primarily by children 12 years of age and under manufactured or imported on or after February 28, 2018 must be tested by third party labs and be certified in a Children’s Product Certificate as compliant to
the federal toy safety standard enacted by Congress and to other applicable requirements as well. Common requirements for children’s products include, but are not limited to, lead, lead in paint, phthalates, small parts, and tracking labels.
(From CPSC, Toy Safety Business Guidance & Small Entity Compliance Guide)
QIMA is a Consumer Product Safety Commission (CPSC) accepted laboratory and is accredited to facilitate third party testing which will enable you to show your toy product complies with all necessary toy standards in the US.
What is a Children's Product Certificate in US?
A Children's Product Certificate is a confirmation that certifies a children's product complies with all applicable children's product safety rules. The certification must be based upon the results of third party testing. The third party testing laboratory
provides the testing services and results but does not issue the Children's Product Certificate. The Children's Product Certificate must be issued by the importer for products manufactured overseas. The Children's Product Certificate must
be issued by the U.S. manufacturer for products manufactured domestically.
(From CPSC, Children's Product Certificate (CPC)
A model of a Children's Product Certificate can be found in the link below:https://www.cpsc.gov/Testing-Certification/Childrens-Product-Certificate-CPC
Is a Children's Product Certificate required if I sell directly to consumers and do not use retailers or distributors in US?
The law requires manufacturers or importers to issue a Children's Product Certificate with the following criteria:
1. The certificate accompany each product or shipment of products
2. The certificate be furnished to retailers and distributors
3. The certificate be provided to the Consumer Product Safety Commission (CPSC) upon request.
You do not have to provide the certificate to consumers in direct-to-consumer sales.
(From CPSC, FAQ - Certification and Third Party Testing)
Is a Children's Product Certificate required for each shipment of product in US?
Yes. The law requires each import (and domestic manufacturer) shipment to be "accompanied" by the required certificate. The requirement applies to imports and products manufactured domestically. Under CPSC regulations, an electronic certificate is
"accompanying" a shipment if the certificate is identified by a unique identifier and can be accessed via a World Wide Web URL or other electronic means, provided the URL or other electronic means and the unique identifier are created in advance
and are available with the shipment.
(From CPSC, FAQ - Certification and Third Party Testing)
Does the packaging for child care articles and children's toys need to comply with the prohibition of phthalates in the US?
Packaging is generally not intended for use by children when they play, given that most packaging is discarded and is not used or played with as a children's toy or child care article.
However, if the packaging is intended to be reused or used in conjunction with a child care article or with a children's toy while playing, such as a heavy-gauge reusable bag used to hold blocks, it would be subject to the prohibition on phthalates.
(From CPSC, Phthalates Business Guidance & Small Entity Compliance Guide)
What types of products are considered as art materials under US requirements?
An “art material” or “art material product” is defined as any substance marketed or represented by the producer or repackager as suitable for use in any phase of visual or graphic art creation with any medium and package sizes intended for individual
users of all age or those participating in a small group.
(From CPSC, Art Materials Business Guidance)
What is needed to ensure that art materials are complying with the chronic hazard requirements under the Labeling of Hazardous Art Materials Act (LHAMA) in US?
Under the LHAMA requirements in the US Code of Federal Regulations, Title 16, Part 1500 - Hazardous Substances and Articles; Administration and Enforcement Regulations (16 C.F.R. § 1500.14(b)(8)(i)(C)(1), the producer or repackager of art materials
must submit the art materials product formulation(s) or reformulation(s) to a toxicologist to have the product assessed for the potential to cause adverse chronic health effects before the products enter the market.
The regulation also requires
the manufacturer or repackager to submit to the CPSC, the criteria that the toxicologist uses to complete the assessment of the product, along with a list of art materials contained in the product that require chronic hazard warning labels under
LHAMA. The submission requirement is at 16 C.F.R. § 1500.14(b)(8)(ii)(C).
(From CPSC, Art Materials Frequently Asked Questions)
What care label regulations are required in the Australia market?
Care labels for textile articles in the Australian market must comply with the Trade Practices Act 1974 - Consumer Protection Notice No. 25 of 2010 - Consumer Product Information Standard: Care Labelling for Clothing and Textile Products. Additional
required details are outlined in the Australian/New Zealand Textiles - Care Labelling, AS/NZS 1957-1998 standard.
Is there any UV400 requirement within AS/NZS 1067.1 :2016 Eye and face protection - Sunglasses and fashion spectacles?
In Australian & New Zealand standard, there is a UV range requirement of AS/NZS 1067.1:2016 which covers the range of 280nm to 400nm. This is called “UV protection”. If the sunglasses has a claim of UV400 protection, AS/NZS
1067.1:2016 clause .18.104.22.168 -UV400 mentioned a separate test method covering the range of 190nm to 400nm to check if the lens provides UV400 protection.
What is the California Proposition 65 Requirement in the US?
The official name of Proposition 65 is the Safe Drinking Water and Toxic Enforcement Act, which was enacted in 1986. It requires businesses to provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects
or other reproductive harm. These chemicals can be in the products that Californians purchase, in their homes or workplaces, or may be released into the environment. The required warnings under Proposition 65 enable Californians to make
informed decisions about their exposure to these chemicals.
Proposition 65 also prohibits California businesses from knowingly discharging significant amounts of listed chemicals into sources of drinking water.
Proposition 65 requires California to publish a list of chemicals known to cause cancer, birth defects or other reproductive harm. This list, which must be updated at least once a year, has grown to include approximately 900 chemicals since it
was first published in 1987.
The Proposition 65 chemical list can be found at: https://oehha.ca.gov/proposition-65/proposition-65-list
Testing will usually be performed by a risk assessment approach as well as for substances commonly targeted by California Proposition 65 settlements, for example: Phthalates, lead, cadmium, etc.
If your product contains phthalates, lead, cadmium or other Proposition 65 listed chemicals, you are required to provide a “clear and reasonable” warning if the consumer will be exposed to levels of the chemical that may pose a risk of cancer,
birth defects or other reproductive harm. This warning is often represented as a label on the product or packaging.
On Product Warning (example)
On Product Short Form Warning (example)
(Definition from California Office of Environmental Health Hazard Assessment (OEHHA)
Are products that are labeled with a Proposition 65 warning safe?
The aim of Proposition 65 is to notify consumers that they are being exposed to chemicals that are known to cause cancer and/or reproductive toxicity. Consumers can decide on their own if they want to purchase or use the product. A Proposition 65
warning does not necessarily mean a product is in violation of any product-safety standards or requirements.
What is REACH?
REACH is a regulation of the EU, effective from 1 June 2007, that deals with Registration, Evaluation, Authorization and Restriction of Chemical substances. By managing the risk from chemicals and providing safety information on substances, REACH
aims to improve the protection of human health and the environment as well as to enhance the competitivenes of the chemical industry in the EU.
Manufacturers, importers and/or retailers with products entering EU have different obligations according to the REACH regulation. Registration, notification and authorization with European Chemicals Agency (ECHA) is also necessary under different
The regulation also focuses on the progressive substitution of the most dangerous chemicals (referred to as "substances of very high concern, SVHC") when suitable alternatives have been identified.
Most consumer products fall under the scope of REACH regulation, with the following exclusions:
1. Radioactive substances
2. Substances in temporary storage under customs supervision, provided they are not being transformed or processed in any way
3. Substances used in the interest of defense when they are covered by specific national exemptions
4. The transport of hazardous substances on their own or in mixtures
5. Non-isolated intermediates – substances that appear between two successive chemical reactions and are not removed from the system, except for sampling
The registration and authorization requirements do not apply to substances used in:
1. Scientific research and development
2. Food and feedstuffs
3. Medicinal products
Registration is not required for substances:
1. That present minimum risk because of their basic properties (e.g. water, nitrogen) listed in Annex IV of REACH
2. Occurring in nature (e.g., minerals, ores and ore concentrates that are not chemically modified) where registration is deemed inappropriate or unnecessary (see Annex V of REACH)
3. Already registered, then exported from and re-imported into the EEA, by an actor in the supply chain
4. Already registered and recovered through a waste recovery process
Is testing in accordance with REACH regulations required? How is it determined which REACH tests are applicable?
Compliance with REACH is mandatory but testing is not mandated; QIMA in general will assess for risk and potential for non-compliance and test accordingly for certain high risk items. The client can also identify the test items (materials/products
and components) which they want to test.
What is SVHC as referenced in the European (EU) market?
SVHC is the short name for Substances of Very High Concern, as defined in the REACH regulation. Chemical substances with the following hazardous properties may be identified as SVHCs:
- Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B in accordance with the CLP Regulation
- Substances which are persistent, bio accumulative and toxic (PBT) or very persistent and very bio accumulative (vPvB) according to REACH Annex XIII
- Substances on a case-by-case basis, that cause an equivalent level of concern as CMR or PBT/vPvB substances
- Substances with evidence for similar concern, such as endocrine disruptors
The Candidate List of SVHCs for Authorisation is published and updated in the European Chemicals Agency (ECHA) website:
According to Article 33 of the REACH regulation, importers/manufacturers of items with a concentration of any SVHC above 0.1% weight by weight must disclose this information to their customers (including safety concern and instruction) within
45 days upon request.
According to Article 7 of the REACH regulation, importers/manufacturers must also submit a notification to ECHA if they produce/import articles that contain more than 1 tonne per year of any SVHC substance, with a concentration above 0.1% weight
The concentration of SVHC substances in articles can be determined by testing against the SVHC list from ECHA.
What is considered to be a cosmetic in Europe (EU) and in the US?
A cosmetic in the EU is any substance or mixture of substances intended to be placed in contact with the human body for use in cleaning, perfuming, changing appearance, protecting, keeping in good condition, or correcting body odors. A sanitizer
will not be regarded as a cosmetic.
A cosmetic in the US is a product that is intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body‘s structure or functions (with the exception of
"true soap," or soap which does not have odor or any other function besides cleaning). A cosmetic may also be classified as a drug in certain circumstances, such as antimicrobial hand wash/hand lotion or a makeup product marketed with a Sun
Protection Factor (SPF).
What is a Harmonized Standard?
Harmonization is the effort to reconcile conflicting and redundant standards across the EU. In the EU, a harmonized standard is one that has been developed by a recognized European Standards Organization (CEN, CENELEC or ETSI) to meet requirements
from the European Commission. Harmonized standards detail how products, services, or processes can comply with relevant EU legislation. Economic operators (manufacturers, importers, etc.) and conformity assessment bodies use harmonized standards
to determine whether or not products, services, and processes are compliant.
If a product meets the requirements stated in a harmonized standard, it will conform to European legislation/directive(s) that list the standard in their Official
What is QIMA’s practice for California Proposition 65 (CA Prop 65) testing for the state of California and the U.S. market?
In general, the market practice for compliance with CA Prop 65 is to reference previous legal settlements for litigations of similar products. Testing will follow a previous litigation settlement where a specified limit of content has been identified
for a specific hazardous chemical in the product.
The aim of CA Prop 65 is no hazardous chemical exposure to the consumer. If a hazardous chemical is present and there is potential exposure, a CA Prop 65 warning is required. If the product has no previous product litigations, testing is recommended
for the presence of lead, cadmium and phthalates as a reference in limiting potential liability issues to the manufacturer/distributor and exposure issues to the consumer.
What are the different types of standards in China?
There are five levels of Chinese standards. The most widely implemented are the National Standards which include mandatory and optional tests, followed by Professional Standards which are optional by nature, then Local Standards, Groups Standards
and finally Enterprise Standards.
These levels are hierarchical. Local Standards supersede Enterprise Standards, Professional Standards supersede Local Standards, etc. For any given product or service, only one type of Chinese standard will apply.
1. Chinese mandatory national standards, commonly refered to as "GB standards," can be identified by the prefix code GB. Voluntary national standards have a prefix code of GB/T.
2. Professional Standards are commonly known as “Industry Standards.”
They apply when no National Standard exists. Professional Standards are coded by industry, and voluntary industry standards have /T added.
3. Local Standards are often referred to as “Provincial Standards.” They are developed when
no National Standards or Professional Standards apply. Local Standards are coded DB (mandatory) and DB/T (voluntary).
4. Group Standards are often referred to as “Association or Organization Standards”. They are also developed when no National
Standards or Professional Standards are available.
5. Enterprise Standards may be developed and/or used by an individual company in China in cases where none of the other types of standards apply. Enterprise standards can be identified
by the prefix of Q.
What is a Children's Product Certificate in US?
A children's product certificate (CPC) is a statement, in the form of a certificate issued by a manufacturer or importer, that says a product complies with all applicable children's product safety requirements. The certification must be based
on the results of third party testing by a Consumer Product Safety Commission (CPSC) accepted laboratory.
The third party testing service provides test results, but does not issue the certificate. For products manufactured overseas, the certificate must be issued by the importer. For products manufactured domestically, the certificate must be issued
by the U.S. manufacturer. A model of a CPC can be found in the link below:
To support importers and manufacturers, QIMA offers services to help you draft/prepare your CPC.
Is a children's product certificate (CPC) required if I sell directly to consumers and do not use retailers or distributors in the US?
Yes, a CPC is required even if you sell directly to consumers. If there is product safety issue, you will need to present a CPC to CPSC as proof of compliance.
What is a small part and what is the size requirement related to a small part in the US market?
A small part is any object that fits completely into a specially designed test cylinder 2.25 inches long by 1.25 inches wide that approximates the size of the fully expanded throat of a child under three years old. Toys and other articles that are
intended for use by children under three and that are or have small parts, or that produce small parts when subject to use and abuse testing are prohibited. To assess, the toy itself, any components or pieces in the as received state (excluding
paper, fabric, yarn, fuzz, elastic, and string), and pieces/parts which have become detached as a result of use and abuse testing shall be placed into the cylinder, one at a time. If any toy, component, or piece fits entirely within the
cylinder, in any orientation and without being compressed, the article fails to comply with the US small part requirement.
What is the meaning of the Conformitè Europëenne (CE) marking on a toy in the in the European Union (EU) market?
"CE marking" is a mark by which a manufacturer indicates that a product is in conformity with applicable European performance and safety standards set out in EU harmonization legislation.
The CE mark shall be affixed visibly, legibly and indelibly
to the toy, to an affixed label, or to the packaging. In the case of small toys and toys consisting of small parts, the CE marking may alternatively be affixed to an accompanying leaflet. Where the CE mark is not visible from outside the packaging,
if any, it should as a minimum be affixed to the packaging.
Further, the presence of CE marking indicates that the appropriate technical documentation supporting the use of the mark is available and can be provided by the manufacturer, importer, or person responsible for placing the product on the EU market
The CE marking specification:
1. The CE marking should consist of the initials "CE" taking the following form:
2. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing in point 1 should be respected
3. Where specific legislation does not impose specific dimension, the CE marking should be at least 5 mm high
Reference link: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0030:0047:en:PDF
What information needs to be included in the Consumer Product Safety Information Act (CPSIA) tracking label for the U.S. market?
Children’s products that are designed or intended primarily for use by children ages 12 or younger must have distinguishing permanent marks referred to as tracking labels that are visible and legible, affixed to the product and packaging and contain
identifying information as follows:
- Manufacturer or private labeler name
- Location and date of production of the product
- Detailed information on the manufacturing process, such as batch number, run number, or other identifying characteristics
- Any other information
required to facilitate ascertaining the specific source of the product
All tracking label information should be visible and legible.
Refer link: https://www.cpsc.gov/business--manufacturing/business-education/tracking-label/
What is considered to be a durable infant or toddler product in the US market?
A durable infant or toddler product is a durable product intended for use, or that may be reasonably expected to be used, by children under the age of 5 years and includes the following items:
|Baby Changing Products
||Gates and Enclosures
|Bassinets and Cradles
||Hand-Held Infant Carriers
||Portable Bed Rails
||Infant Bath Seats
||Portable Hook-On Chairs
|Carriages and Strollers
||Infant Bath Tubs
|Children's Folding Chairs and Stools
||Infant Bouncer Seats
||Soft Infant and Toddler Carriers
|Cribs (Full-size and non full-size)
||Infant Inclined Sleep Products
||Stationary Activity Centers
|Frame Child Carriers
Reference link: https://www.cpsc.gov/Business--Manufacturing/Business-Education/Durable-Infant-or-Toddler-Products/
In what condition would the filling material in plush toys be declared unfit for sale in the state of Pennsylvania in the US?
The Bureau of Occupational and Industrial Safety (BOIS) administers and enforces safety standards related to Pennsylvania's Stuffed Toy Laws. Stuffing material must meet specific criteria, including:
1. Material of sufficient size to visibly reveal a pattern, weave, or other mechanical unification of threads to indicate prior use or a previous manufacturing process
2. Dirt or any other foreign matter in excess of 1% by weight
than 1% oil or grease
4. More than 0.002% lead (as Pb) 20 parts per million
5. More than 0.0002% arsenic (as AS2O3 two parts per million)
6. More than 5% ammonia
7. More than 1% urea
8. Plastic or metal ornaments such as eyes
and nose without a safe design or if they are not attached to the stuffed toy to prevent removal
9. Stones or other hard materials having jagged or sharp edges
10. Material bearing electrostatic charge with adherence characteristics
which when exposed could lodge in the windpipe, ears or nostrils
11. Filling material which surface burns at a rate of less than three seconds for 12 square inches
It should be noted that other requirements apply to stuffed toys and, in addition to national labeling requirements, there are other state specific requirements in the US. For example, Pennsylvania, Massachusetts and Ohio require stuffed toy manufacturers
to register with the state and submit information and examples of toy filler content for pre-approval. Once approved, the state will issue a license number which must be shown on the label.
Reference link: https://www.dli.pa.gov/Individuals/Labor-Management-Relations/bois/Pages/Stuffed-Toys-Regulations.aspx#312
In Europe, do blankets and objects intended to facilitate sleep for children during transportation fall within the scope of Entry 51 and 52 of REACH Annex XVII?
The guideline on “which can be placed in the mouth” in entry 52 of Annex XVII to REACH provides certain clarifications concerning the types of childcare articles within the scope of Entries 51 and 52 in Annex XVII. For instance, sleeping bags are
claimed to be articles designed to facilitate sleep, and should therefore fall under the scope of Entries 51 and 52. In addition, the guidance document explicitly contains a photo of a mattress cover which is considered as a childcare article,
also explains that certain parts (e.g., mattress protectors) can be placed in the mouth by children.
Blankets are, in nature, articles similar to mattresses as both are used in bed to facilitate the sleeping of children and therefore
can be claimed to meet the broad definition of childcare articles. Furthermore, since children commonly place blankets in their mouths, these can be considered within the scope of both Entries 51 and 52 of Annex XVII.
clarifies that, "entry 52 of Annex XVII on what can be placed in the mouth by children also covers the accessible parts of articles such as push chairs, car seats, sleeping bags and bike seats which are intended to facilitate sleep and relaxation
during transportation." Given that child seats and items which are used for transportation of children are quite similar in function and design to the above mentioned types of articles, they can be broadly considered as childcare articles.
What flammability testing requirements does a children's sleeping bag need to comply with in the U.S. market?
For children's sleeping bags exported to the US, the Canvas Products Association International CPAI-75 standard for flammability of sleeping bags is applicable. This standard was developed by the Industrial Fabrics Association International which
represents the global industrial fabrics industry. The flammability testing method is ASTM F1955, Standard Test Method for Flammability of Sleeping Bags.
What technical documentation is the manufacturer obligated to draw up for a toy being placed on the European Union (EU) market?
Here is the list of documentation to be kept on file for a toy in the EU marketplace:
1. A detailed description of design and manufacture, including a list of components and materials used in the toy as well as safety data sheets on chemicals
used (if any)
2. Safety assessment report
3. A description of the conformity assessment followed
4. A copy of the EC declaration of conformity
5. Address(es) of manufacture and storage
6. Copies of documents that the manufacturer
submitted to a notified body
7. Test reports
8. A copy of the EC-type examination certificate (if any)
In what circumstances would a toy be submitted for an EC-type examination?
EC-type examination is a part of conformity assessment procedure in which a notified body examines the technical design of a product, verifies and attests that the technical design of the product meets the Toys Safety Directive 2009/48/EC.
"In the following cases, a toy shall be submitted to an EC-type examination to evaluate safety for a child:
1. When harmonized standards, the reference number of which has been published in the Official Journal of the European Union, covering
all relevant safety requirements for the toy, do not exist;
2. When the harmonized standards referred to in point (1) exist but the manufacturer has not applied them or has applied them only partly;
3. When one or more of the harmonized
standards referred to in point (1) has been published with a restriction;
4. When the manufacturer considers that the nature, design, construction or purpose of the toy necessitate third party verification."
In the U.S., is it required to have the exact manufacturer name and address on the tracking label of a chilrdren's product?
What are the scopes for migration of certain elements in toys in The U.S., EU, Australia and New Zealand?
For the purposes of standard EN 71-3 (Europe), ASTM F963-17 (USA), and AS/NZS ISO 8124.3 (Australia/New Zealand), the requirements relative to migration of certain elements in these documents apply to the following toys and toy components and
materials where the likelihood of sucking, licking or swallowing is considered to be significant:
- All toys intended to be put in the mouth or up to the mouth, cosmetic toys and writing instruments categorized as toys can be considered to be able to be sucked, licked or swallowed;
- All the accessible parts and components of toys intended
for children up to 6 years of age can be considered to come into contact with the mouth. The likelihood of mouth contact with parts of toys intended for older children is not considered significant in most cases.
Please note that the requirements do not apply to toys or parts of toys which, due to their accessibility, function, volume or mass, clearly exclude any hazard due to sucking, licking or swallowing or prolonged skin contact when the toy or part
of toy is used as intended or in a foreseeable way, bearing in mind the behavior of children.
What flammability testing method should children's daywear and nightwear be subjected to for the Australian and New Zealand markets?
For the Australia and New Zealand markets, children's daywear and nightwear must comply with the mandatory flammability testing standard AS/NZS 1249-2014 Amd 2 (Children’s Nightwear and Limited Daywear and Paper Patterns for Children’s Nightwear)
The safety standard incorporates results of a substantial review of the voluntary Australian/New Zealand Standard, AS/NZS 1249 Children’s nightwear and limited daywear having reduced fire hazard (AS/NZS 1249: 2003
as varied) on which the previous safety standard is based. The Australian Competition and Consumer Commission (ACCC) has monitored children's sleepwear compliance and published recall cases on these product categories.
Where should the permanent label be sewn on close-fitting clothing for infants according to GB 31701-2015 for the China market?
The permanent label sewn on close-fitting infant and baby clothing should be placed away from direct skin contact. For example: the label can be attached on the outer trim or outside of the clothing item.
Is it acceptable to state both “Do Not Tumble Dry” & “Line Dry” on the care label for the US market?
"Do not tumble dry" is not needed if the label states "Line dry". However, it is acceptable to have both statements, because they do not contradict with each other.
According to ISO 105-X18:2007 Assessment of the potential to phenolic yellowing of materials, what factors would result in phenolic yellow failure and what can be done to improve it?
In the process of storage of textiles, the reaction of packaging material (including Butylated hydroxytoluene (BHT)) and nitrogen oxides can result in the phenol yellowing; alkaline environments are more favorable for this. Phenolic yellowing has
a pure bright yellow color, and fades when exposed to light or ozone. The yellow product dissolves in hot water and it becomes colorless in an acidic medium with a pH of 5 or lower.
Factors that can be considered for improvement:
using brown paper, brown cardboard and plastic film containing BHT to package finished products.
b. Avoid alkalinity in finished products.
c. Use an anti-phenolic yellowing agent.
Are children's theatrical costumes and dancewear required to go through testing for cords and drawstrings based on European Standard EN 14682?
EN 14682 specifies requirements for cords and drawstrings on children's clothing, including disguise costumes and ski apparel for children up to the age of 14 years. Based on the scope and context of EN 14682, specialized sportswear and activity wear
generally worn for limited periods and under supervision (for example rugby shorts, wet suits, dancewear, and theatrical costumes used for theatrical performance) are not included in the scope, except where those garments are commonly worn as
daywear or night wear.
In the US market, does a headband (for children <24 months in age) need to comply with the US Code of Federal Regulations, 16 CFR 1610 standard for the flammability of clothing textiles requirement?
The 16 CFR 1610 standard provides methods of testing the flammability of clothing and textiles intended to be used for clothing.
A headband, same as hat (headwear), is exempt from this requirement. The specific exception is listed in the standard as follow (there are other exceptions listed as well but not included here):
"Specific exceptions. This standard shall not
apply to: (1) Hats, provided they do not constitute or form part of a covering for the neck, face, or shoulders when worn by individuals;..."
What information is required on the label of an apparel or textile item in China?
GB 5296.4-2012 "Instructions for use of products of consumer interest, Part 4: Textiles and apparel” is the mandatory Chinese standard in effect. All textiles and apparel sold in China fall into its scope which outlines labeling requirements.
information contained on the label must be presented in simplified Chinese. Including additional language(s) is optional, but the text (character) size should be no larger than the corresponding Chinese characters.
The standard specifies
the requirement for product labeling including product name, product size, quality grade, fiber composition, care instruction, name & address of the manufacturer, and also references product safety standard code and item category (based on
GB 18401 & GB 31701).
How can failed results for phthalate content be avoided and why are phthalates present in plastics and printed materials?
Phthalates include the various salts/esters of phthalic acid which are frequently added to plastics to increase flexibility. Phthalates are often associated with flexible plastic components and trims, such as prints on garment. For rigid plastics,
the risk of having failed results for phthalate content is smaller, but phthalate testing is still strongly advised.
When we test for phthalate content, we focus more on soft plastics and prints such as print paste which has phthalate in its composition.
To reduce the risk of phthalate contamination when sourcing textiles:
(I) Check with manufacturers and printing mills directly and confirm that they restrict and monitor the use of phthalates in print pastes (formulations).
the manufacturers to test each and every Bill of Materials (BOM) for printing formulation/print paste before starting production.
(III) Manufacturers should replace any non-compliant phthalate finding in point II with phthalate-free ingredients.
In Europe, what is the meaning of "textile articles which can reasonably be expected to be washed in water" and "new textile articles produced exclusively from recycled materials" in the context of REACH Annex XVII, entry 46a on nonylphenol ethoxylates?
"Textile articles which can reasonably be expected to be washed in water" is related to the use of care indications on the label attached to the textile article. Textile articles with care instructions that exclude washing in water and require
dry cleaning are, in principle, not covered by the restriction in paragraph 1 of entry 46a. However, care instructions should not be used to circumvent the restriction, such as by using a label for dry cleaning where there is no need for dry
"New textile articles produced exclusively from recycled textiles" means that REACH Annex XVII, entry 46a on nonylphenol ethoxylates (NPE) does not apply to textile articles that are produced exclusively from recycled textiles. This exemption
is not applicable for textiles that are not produced exclusively with recycled materials. For example, if virgin textiles materials have been used together with recycled ones during production, the exemption does not apply.
What is the scope of European Standard EN 14682 as it relates to children's clothing and how are the affected age groups divided?
This European standard specifies requirements for cords and drawstrings on children's clothing, including disguise costumes and ski apparel, up to the age of 14 years.
The standard divided age groups as follow:
- Children up to 7 years – corresponding to children up to 134 cm tall.
- Children 7-14 – corresponding to children taller than 134 cm and up to 182 cm for boys and up to 176 cm for
Is the China Compulsory Certification (CCC) mark required for clothing and textile products?
No, clothing and textile products do not require a CCC Mark. Only high-risk products such as toys, children's bicycles and electrical appliances need a CCC Mark issued by certification bodies and labs authorized by Certification and Accreditation
Administration of the People's Republic of China (CNCA).
What is a European Union Directive?
"A 'directive' is a legislative act that sets out a goal that all EU countries must achieve." Each individual country is responsible for developing its own laws to achieve the goal. Directives differ from EU Regulations in that regulations "must
be applied in its entirety across the EU". Directives usually leave a certain amount of leeway for member states to determine the exact rules to be adopted. Directives can be adopted through various legislative procedures, depending on the
Definition from European Union: https://european-union.europa.eu/institutions-law-budget/law/types-legislation_en
What is a Notified Body in the European Union?
A Notified body is a certification body designated by the notifying authority of a European Union Member State to perform the tasks relating to the conformity assessment procedures referred to in the applicable New Approach directive, when a third
party is required.
The Notified bodies (by directive or by country) can be identified by searching in the NANDO (New Approach Notified and Designated Organizations) Information System.
(Definition from European Commission)
Is the UL / ETL mark for Electrical and Electronics (E&E) safety compulsory for the US market?
No, the safety report and certificate must be from a Nationally Recognized Testing Laboratory (NRTL); UL and ETL, a division of Intertek, are just two of the NRTL labs. Other NRTL labs (there are twenty) have the same ability to assess and
confirm compliance. What is compulsory in the US market is that the safety test report verifying compliance is issued by one of the NRTL laboratories, which include UL and ETL.
Some UL standards such as UL 62368-1, has become IEC 62368-1 and are compulsory for the US market.
What is the compulsory date for the UK Conformity Assessment (UKCA) mark to be placed on Electrical and Electronics (E&E) products in Great Britain (GB)?
Important dates to note for the UKCA mark:
1 January 2021 - 31 December 2022: UKCA transition period – For products placed on the market during this time period, both the UKCA and the European Conformity (CE) marks are acceptable.
1 January 2021: Mandatory start
date for UKCA marking – UKCA is required if the product requires 3rd party conformity assessment and the assessment must be carried out by the British Conformity Assessment Agency.
1 January 2023: Mandatory use of UKCA mark – CE marking
will no longer be accepted.
The CE marking is only valid in Great Britain when GB and European Union (EU) rules remain the same. If EU requirements change and the CE mark is on your product on the basis of the new rules, you will not be
able to use the CE marking to sell in Great Britain, even before 31 December 2022.
What is the application of ASTM International standard F3502, Standard Specification for Barrier Face Coverings?
This specification is primarily intended to help ensure barrier face coverings meeting the stated requirements provide (1) a means of source control for individual wearers by reducing the number of expelled droplets and aerosols from the wearer’s
nose and mouth into the air; and (2) to potentially offer a degree of particulate filtration to reduce the amount of inhaled particulate matter by the wearer.
The standard was primarily established in response to the global COVID-19
pandemic beginning in 2019 to address a product that is neither a medical face mask per ASTM Specification F2100 for providing source control, nor a respirator for providing inhalation protection as defined by regulatory requirements specified
in the United States under 42 CFR Part 84.
|Barrier face covering
||A product worn on the face, specifically covering at least the wearer’s nose and mouth, with the primary purpose of providing source control and to provide a degree of particulate filtration to reduce the amount of inhaled particulate
|Medical face mask
||An item of protective clothing designed to protect portions of the wearer’s face, including the mucous membrane areas of the wearer’s nose and mouth, from contact with blood and other body fluids during medical procedures.
||Personal protective equipment (PPE) designed to protect the wearer from inhalation of hazardous contaminants.
Should manufacturers test all colors of the same face coverings with the same construction and design to stay compliant with ASTM F3502 standard specification for barrier face coverings?
The standard does not indicate testing for different colors of the same fabric. If the fabric is identical with the exception of color, only one representative fabric would need to be tested.
The ASTM standard specification for barrier face coverings, ASTM F3502 section 5 design requirements, does not contain specific test requirements and methods for certain items such as sizing requirement, tolerance and leakage assessment, how to determine
if the coverings will not be damaged by ordinary handling, donning and doffing, etc. What would be required to show product compliance?
Since Section 5 is design oriented, it provides an overview of considerations, based on design aspects of the product. There is no specific test criteria to assess these design components other than if the manufacturer wants to do any of the following:
make specific claims (e.g., flame resistance)
- demonstrate non-toxicity (by applying biocompatibility testing)
- conduct the optional quantitative leakage factor testing (per ASTM F3407, as modified in the subject standard)
If there is no associated test method, the manufacturer or other organization involved in the conformity assessment applies their judgment on how the product complies with the respective requirements.
What is a CE mark? What is the purpose of CE mark?
CE is an abbreviation of a French phrase that means "European Conformity".
CE marking is required for many products. It:
- Shows that the manufacturer has checked to confirm products meet European Union (EU) safety, health or environmental
- Is an indicator of a product’s compliance with EU legislation
- Allows the free movement of products within the European market
By placing the CE marking on a product, a manufacturer is declaring, on his sole responsibility, conformity
with all of the legal requirements to achieve CE marking.
Note: The UK Conformity Assessed( UKCA) marking is a new product marking that will be used for placing certain goods in the United Kingdom (UK) market and will be required after
the UK leaves the EU on December 31, 2020. Affixing the mark on a product indicates that the product fulfills all applicable regulations in the UK.
What kind of products need to bear the CE mark?
Products categorized by EU directives are required to bear a CE mark on the product:
1. Toy Safety - Directive 2009/48/EU
2. Transportable Pressure Equipment - Directive 2010/35/EU
3. Restriction of Hazardous Substances in Electrical
and Electronic Equipment - Directive 2011/65/EU
4. Construction Products - Regulation (EU) No 305/2011
5. Pyrotechnic Articles - Directive 2013/29/EU
6. Recreational Craft and Personal Watercraft - Directive 2013/53/EU
7. Civil Explosives
- Directive 2014/28/EU
8. Simple Pressure Vessels - Directive 2014/29/EU
9. Electromagnetic Compatibility - Directive 2014/30/EU
10. Non-automatic Weighing Instruments - Directive 2014/31/EU
11. Measuring Instruments - Directive 2014/32.EU
Lifts - Directive 2014/33/EU
13. ATEX - Directive 2014/34/EU
14. Radio Equipment - Directive 2014/53/EU
15. Low Voltage - Directive 2014/35/EU
16. Pressure Equipment - Directive 2014/68/EU
17. Marine Equipment - Directive 2014/90/EU
Cableway Installations - Regulation (EU) 2016/424
19. Personal Protective Equipment - Regulation (EU) 2016/425
20. Gas Appliances - Regulation (EU) 2016/426
21. Medical Devices - Regulation (EU) 2017/745
22. In Vitro Diagnostic Medical
Devices - Regulation (EU) 2017/746
23. EU Fertilising Products - Regulation (EU) 2019/1009
Can the CE mark be placed on a product if it is not required?
What are the differences between obtaining the European Conformity (CE) and UK Conformity Assessment (UKCA) mark?
Both the UKCA and the CE mark are government mandated conformity marks. Affixing the mark on a product indicates that the product fulfills all applicable Directives and Regulations in the UK and the EU, respectively.
The CE mark is a conformity mark and it is based on the self-certification and mandatory third-party conformity assessment carried out by an EU-27 recognized Notified Body. After Brexit, the CE mark will still be allowed for a limited time on
the UK market.
The UKCA Mark is a conformity mark issued by a UK Approved Body and is applicable to certain goods after Brexit. The CE mark will not be accepted by Great Britain in place of the UKCA mark after 1 January 2023.
Are requirements for Polycyclic aromatic hydrocarbons (PAHs) mandatory in Germany?
In EU, PAH requirement in consumer products is regulated by REACH, under Annex XVII, item 50. 8 PAH substances are under concern by REACH restriction. PAHs is not a legal requirement by the German Product Safety Commission (AfPS), but 15 PAH substances
are under concern. It is only compulsory to test when the Geprüfte Sicherheit (GS) mark is applied.
However, due to the many market surveillance activities in Germany by authorities, non-government organizations (NGOs), consumer magazines,
etc. and the media attention being focused on PAHs having been tested using the AfPS method, it is highly recommended.
In Europe, are batteries within the scope of the directive for the Restriction of (the use of certain) Hazardous Substances (RoHS)? Which directive applies to the outer casings of battery packs? Is it the RoHS or the Batteries Directive?
No. Recital 14 of RoHS 2 specifically states that RoHS should apply without prejudice to the Batteries Directive; therefore, batteries are not within the scope of RoHS.
Recital 29 of the Batteries and Accumulators Directive (2006/66/EC) states
RoHS does not apply to batteries and accumulators used in electrical and electronic equipment.
According to the Batteries Directive, battery packs are also batteries, therefore, the Batteries Directive applies to battery packs, including their
Does the Council of Europe’s guidance on metals and alloys used in food contact materials and articles (CM/Res(2013)9 ) apply to enameled cookware?
No. The Council of Europe recommendations apply to articles made from metals and alloys, and to metals released from such articles and transferred to food. Enamel coatings are not within the scope. When a metal released from an enamel-coated utensil
exceeds the corresponding Specific Release Limit (SRL), it is not usually possible to say whether the metal comes from the enamel coating or the base metal since the materials cannot easily be separated before testing. In this case the entire
article may not comply with the guide.
There is a CEN (European Committee for Standardization) approved method, EN ISO 4531-2018 which can be applied to enameled cookware. In EN ISO 4531-2018, the restriction on enameled articles in contact with food is specified.
What food contact materials use bisphenol A (BPA)?
BPA is used in a number of food contact applications. It is a chemical compound and one of the best known bisphenol. The chemical properties of BPA mean it could be used as a monomer or raw ingredient in plastic manufacturing.
In plastic manufacturing, BPA is used to make polycarbonate plastic, which is hard and durable. It is used to produce articles that are intended to be reused, such as water dispensers, molding equipment for confectionary products, drink
bottles, and plastic containers. It is also used to manufacture coatings for food and drink cans. BPA is not however used to make flexible plastic packaging, such as that used for single use water bottles or food wrapping.
What are the next steps of European Commission relative to policy initiatives and impact assessments for ceramic and vitreous food contact materials (FCMs)?
Separately from the main revision of the EU FCM legislation, the Commission is specifically revising rules concerning heavy metals present in ceramic and vitreous FCMs, which include tableware and kitchenware such as plates, cups, mugs, glasses, jugs,
bowls, and oven trays. Vitreous materials include glass, crystal and materials with a glazed coating such as enameled metals. However, recent scientific evidence and enforcement data indicate that the current exposure to lead, cadmium, and several
other metals (aluminum, arsenic, barium, cobalt, chromium and nickel) released from FCMs is of concern. In addition, there is information showing that such metals also transfer from vitreous FCMs. Therefore, based on current health data including
opinions published by the European Food Safety Authority (EFSA), the Commission is considering lowering the limits of lead and cadmium and introducing limits for aluminum, arsenic, barium, cobalt, chromium, and nickel allowed to transfer from
ceramic and vitreous FCMs.
What legal status do the recommendations of the German Federal Institute for Risk Assessment (BfR) have?
The BfR Recommendations on Food Contact Materials are not legal regulations. However, they reflect the current state of science and technology for the conditions under which consumer products of high polymer materials meet the requirements of § 31.1
of the Food, Consumer Articles and Feed Act (LFGB) and Article 3.1.a of Regulation (EC) 1935/2004 in terms of their non-hazardousness for human health. Consequently, food contact materials and articles must be produced in accordance with good
manufacturing practice so that under normal or foreseeable conditions of use, no ingredients are released into foods in amounts which could endanger human health.
Does Denmark have specific legislation for food contact materials other than what is required by the European Union (EU)?
As a member state of the EU, most legal requirements for food contact materials (FCM) in Denmark are harmonized with the EU, but there a few additional requirements outlined in national legislation:
- A ban on the marketing of paper and board FCM when per- and polyfluorinated alkylated substances have been used
- Migration of lead and cadmium from glassware, ceramic and enameled articles including requirements for migration from the mouth
- Positive list of surface biocides for plastic FCM
- The declaration of compliance, which is required for all types of FCM
Producers and importers of food contact materials must provide a declaration of compliance for their food contact materials together with additional supporting information on their food safety management system including as an example, migration
How do I know if the components of my food contact article are compliant with the requirements of the US Food and Drug Administration (FDA)?
There are a number of ways for you to check and see if the component of your food contact article is compliant with the act:
- Consult 21 CFR 174-179 to see if the use of the component is an appropriately regulated indirect additive.
- Consult 21 CFR 182-186 and the list of GRAS Notices to see if the use of the component is Generally Recognized as Safe (GRAS).
Consult 21 CFR 181 to see if the use of the component is Prior Sanctioned.
- Consult the listing of Threshold of Regulation Exemptions.
- Consult the listing of Effective Food Contact Substance Notifications.
If any component of my food contact article is not covered by any of the categories above, what options do I have?
You can choose one of the options below:
i. Submit a Threshold of Regulation Exemption
ii. Submit a Food Contact Substance Notification
iii. Satisfy the Criteria for GRAS status
What is the effective date of United States (US) Federal Regulation (16 CFR 1640) for upholstered furniture and how does it affect existing inventory?
A new Federal Regulation 16 CFR part 1640 is effective as of 25 June, 2021. This new regulation monitors items manufactured, imported, or reupholstered after 25 June, 2021, which must comply with the flammability test requirement of California Technical
Bulletin (TB) 117-2013. This regulation does not affect items manufactured, imported, or reupholstered on or before 25 June, 2021.
This regulation also includes labeling requirements which will begin on 25 June, 2022 and applies to upholstered
furniture manufactured, imported, or reupholstered on or after that date.
The labeling should include the below information:
- Labeling as required and outlined in California Technical Bulletin (TB) 117-2013
"Complies with U.S. CPSC requirements for upholstered furniture flammability."
The label may be a separate label, or it can be added to the bottom of an existing California TB 117-2013 label. Font size and label requirements are also governed
by the regulation.
In the United States, where and how is upholstered furniture defined?
Upholstered furniture” is defined in the COVID–19 Regulatory Relief and Work From Home Safety Act in Section 2101 (b)(4). This definition can also be found in 16 CFR part 1640.3(e). Upholstered furniture, excluding specific exemptions in the Act,
includes general-use and children’s seating furniture that meet all of the specifications below:
- Is intended for indoor use
- Is movable or stationary
- Is constructed with an upholstered seat, back, or arm
- Is (A) made or sold with a cushion or pillow, regardless of whether that cushion or pillow is attached to or detached from
the furniture; or (B) stuffed or filled, or able to be stuffed or filled, in whole or in part, with any material, including a substance or material that is hidden or concealed by fabric or another covering, including a cushion or pillow belonging
to, or forming a part of, the article of furniture
- Together with the structural units of the furniture, any filling materials, container and covering that can be used as a support for the user's body parts when the individual sits in
an upright or reclining position
What type of information should be included on the packaging of a toy product to meet United States (US) and European Union (EU) labeling requirements?
US Toy Labeling Requirements
1. Consumer Product Safety Improvement Act (CPSIA) tracking label requirements:
- Manufacturer or private labeler name
- Location and date of production of the product
- Detailed information
on the manufacturing process, such as a batch or run number, or other identifying characteristics
- Any other information required to facilitate ascertaining the specific source of the product
2. Uniform Packaging and Labeling Act (UPLA)
- Identity of the commodity
- Name and place of business of the manufacturer, packer, or distributor
- Net quantity of contents in terms of weight, mass, or numerical count in a uniform location on the principal display panel
3. Country of origin
4. ASTM F963 warning statements as applicable based on the product age grade and features
European Toy Labeling Requirements
- Name and address of manufacturer / authorized representative / importer
into the community / distributor
- Type, batch, serial or model number
- Washing instructions for textile toys intended for use by children under 36 months (if applicable)
- EN71-1 Warning Statements as applicable based on the product
age grade and features
- CE marking
* Warning and safety statements/instructions shall be written in the primary languages understood by consumers of the country in which the toy is to be sold.