Knowledge Base (FAQs)

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.

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.

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.

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.

- A respiratory protective device designed for a very close facial fit with an outer edge, designed to seal around the nose and 
  mouth
- Provides efficient filtration against inhaling hazardous airborne particles, gases and vapors
- Provides a relatively high level of protection

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. 

b. PFE - 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. 

c. Resistance 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. 

d. Differential Pressure
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
The 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.

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.

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.  


                                                                                                 

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. 

Marked = Claimed 
Therefore, as a claim, the transmittance requirement of polarization function must be tested.

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%.

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%

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). 

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.

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.

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” be​ing 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 of bamboo.

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.

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.

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.

From ASTM F2100 - Standard Specification for Performance of Materials Used in Medical Face Masks

Characteristic	Level 3 Barrier
Bacterial filtration efficiency (BFE), %	≥98
Differential pressure, mm H2O/cm2	<6.0
Sub-micron particulate filtration efficiency at 0.1 micron (PFE), %	≥98
Resistance to penetration by synthetic blood, (mmHg)	160
Flame spread Class 1 means the material exhibits normal flammability and is acceptable for use in clothing	Class 1

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

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)

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)

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)

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.

Yes. 
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 .3.5.2.8 -UV400 mentioned a separate test method covering the range of 190nm to 400nm to check if the lens provides UV400 protection.

On Product Short Form Warning (example)

(Definition from California Office of Environmental Health Hazard Assessment (OEHHA)

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. 

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.

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 Journal.

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.

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.

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:
https://www.cpsc.gov/Testing-Certification/Childrens-Product-Certificate-CPC 

To support importers and manufacturers, QIMA offers services to help you draft/prepare your CPC.

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.

 

"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 upon request.

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

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/

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	Infant Walkers
Bassinets and Cradles	Hand-Held Infant Carriers	Play Yards
Bedside Sleepers	High Chairs	Portable Bed Rails
Booster Seats	Infant Bath Seats	Portable Hook-On Chairs
Carriages and Strollers	Infant Bath Tubs	Sling Carriers
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	Infant Swings	Toddler Beds

Reference link: https://www.cpsc.gov/Business--Manufacturing/Business-Education/Durable-Infant-or-Toddler-Products/

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
3. More 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

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.
 
The guideline 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. 

Reference: ECHA Guideline

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.

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) 

Reference: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009L0048-20171124    

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."    

Source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009L0048-20171124

Specific to the tracking label, the manufacturer's name must be present in a format that allows the ultimate purchaser to determine the identity of the manufacturer or private labeler.

Reference: https://www.cpsc.gov/Business--Manufacturing/Business-Education/tracking-label

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.

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) Safety Standard. 

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.

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.

"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.

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:
a. Avoid 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.

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.

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;..."

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. 

The 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).

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).
(II)  Ask 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.

"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 cleaning.

"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.

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 girls. 

Reference: https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32011D0196

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). 

Reference: http://www.ccc-cn.org/en/AboutCCC.html

"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 subject matter.

Definition from European Union: https://european-union.europa.eu/institutions-law-budget/law/types-legislation_en

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)

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.

Reference: https://www.osha.gov/nationally-recognized-testing-laboratory-program/current-list-of-nrtls    

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. 

Reference: https://www.gov.uk/guidance/using-the-ukca-marking

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.

Product type	Definition	Diagram
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 matter
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.
Respirator	Personal protective equipment (PPE) designed to protect the wearer from inhalation of hazardous contaminants.

Reference: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=42029

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. 

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.

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 requirements
- 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. 

Reference:
https://www.gov.uk/guidance/ce-marking
https://ec.europa.eu/growth/single-market/goods/new-legislative-framework_en
https://ec.europa.eu/growth/single-market/ce-marking_en

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
12. 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
18. 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

Reference:
https://www.gov.uk/guidance/ce-marking
https://ec.europa.eu/growth/single-market/goods/new-legislative-framework_en
https://ec.europa.eu/growth/single-market/ce-marking_en

Not all products are required to have a CE mark. The European Union directives, known as the "New Approach Directives", define "essential requirements" related to health, safety and environmental issues. The CE mark is compulsory for most of the products covered by the New Approach Directives. It is forbidden to affix CE mark to other products.

Reference:
https://www.gov.uk/guidance/ce-marking
https://ec.europa.eu/growth/single-market/goods/new-legislative-framework_en
https://ec.europa.eu/growth/single-market/ce-marking_en

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.

Reference: https://www.gov.uk/guidance/using-the-ukca-marking

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.

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 outer casings. 

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.

Reference: https://faq.edqm.eu/pages/viewpage.action?pageId=1376783

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.

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.

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.

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 rim
- 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 test results.

Reference: https://www.foedevarestyrelsen.dk/english/Food/Food%20Contact%20Materials/Pages/default.aspx

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 Request
     ii.  Submit a Food Contact Substance Notification
     iii. Satisfy the Criteria for GRAS status

Reference: https://www.fda.gov/food/packaging-food-contact-substances-fcs/determining-regulatory-status-components-food-contact-material

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 
- Statement: "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.

Reference: https://www.cpsc.gov/Business--Manufacturing/Business-Education/Business-Guidance/Upholstered-Furniture

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

Reference: https://www.cpsc.gov/Business--Manufacturing/Business-Education/Business-Guidance/Upholstered-Furniture

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) requirements:
- 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.

Reference:
https://www.cpsc.gov/business--manufacturing/business-education/tracking-label/
https://www.nist.gov/standardsgov/compliance-faqs-packaging-and-labeling-us
https://www.ecfr.gov/cgi-bin/text-idx?node=pt19.1.134&rgn=div5#se19.1.134_111
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009L0048-20191118