Children’s Product Regulations in the European Union: An Overview

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Children's Product Regulations in the European Union

Children’s furniture and various types of childcare articles are usually not considered toys, which means that the Toy Safety Directive is normally not applicable. However, such children’s products are subject to safety standards, substance restrictions, labelling, documentation, and testing requirements.

In this guide, we explain how the GPSR, EN standards, REACH, and food contact materials regulations relate to children’s products. Note that this guide does not cover all EU requirements for children’s products, but it provides a broad overview and can help you understand the basics.


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General Product Safety Regulation

The General Product Safety Regulation (GPSR) replaces the General Product Safety Directive (GPSD). Generally speaking, the GPSR covers all consumer products sold within the EU, regardless of whether there are specific safety requirements or standards for them.

The regulation defines a safe product as:


Any product which, under normal or reasonably foreseeable conditions of use, including the actual duration of use, does not present any risk or only the minimum risks compatible with the product’s use, considered acceptable and consistent with a high level of protection of the health and safety of consumer;


All products, including children’s products, should comply with relevant standards and be manufactured with the user’s safety in mind.

In addition to requiring products to be physically safe, the GPSR also covers labelling and documentation requirements.

Children’s product safety criteria

Children’s products should adhere to the strictest mechanical and physical safety requirements, as it is hard to accurately predict how a child would use a product. A damaged product poses a safety risk as well, particularly for children. You should there consider the product’s uses and potential “misuse” when designing products for children.

For example, a broken product could break into small parts, which might present choking hazards. You should also consider other factors relevant to toy safety, such as flammability, magnets, batteries, and sharp edges.

EN standards

The GPSR requires all products to be safe, regardless of whether standards exist. However, there are many harmonised standards under the GPSD that concern various types of children’s products.

Examples

Standard Reference Number Standard Title
EN 1130:2019,
EN 1130:2019/AC:2020
Children’s furniture – Cribs – Safety requirements and test methods
EN 1130-1:1996 Furniture – Cribs and cradles for domestic use – Part 1: Safety requirements
EN 1130-2:1996 Furniture – Cribs and cradles for domestic use – Part 2: Test methods
EN 1272:2017 Child care articles – Table mounted chairs – Safety requirements and test methods
EN 1273:2005 Child use and care articles – Baby walking frames – Safety requirements and test methods
EN 1400-1:2002 Child use and care articles – Soothers for babies and young children – Part 1: General safety requirements and product information
EN 1400-2:2002 Child use and care articles – Soothers for babies and young children – Part 2 : Mechanical requirements and tests
EN 1400-3:2002 Child use and care articles – Soothers for babies and young children – Part 3 : Chemical requirements and tests
EN 1466:2004 Child care articles – Carry cots and stands – Safety requirements and test methods
EN 1466:2014 Child use and care articles – Carry cots and stands – Safety requirements and test methods
EN 1466:2014,
EN 1466:2014/AC:2015
Child use and care articles – Carry cots and stands – Safety requirements and test methods

Harmonised standards such as the ones listed above cover various products intended for children. However, not all children’s articles or potential risks are covered by a specific standard. In this case, safety requirements still apply to children’s products, so you may need to apply one of the following strategies:

a. Implement all or a portion of another EN standard.

b. Look for standards from outside the EU (for example, ASTM standards in the United States).

c. Independently identify potential risks and define safety requirements and test methods.

For example, it is not unusual for children’s articles such as baby bibs to be tested according to EN 71 requirements, even if it is a standard for toys. Regardless, it is important to rely on standards. If you are unable to find appropriate standards for your product, you should seek assistance from a testing company.

Note: The standards listed above are harmonised under the GPSD, not the GPSR. Although many of the above standards might eventually be harmonised under the GPSR, as far as we are aware, there aren’t currently any standards harmonised under the GPSR.

Labelling requirements

The GPSR sets traceability labelling requirements, in the case a product needs to be recalled. It also sets warning requirements.


5. Manufacturers shall ensure that their products bear a type, batch or serial number or other element enabling the identification of the product and which is easily visible and legible for consumers, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product.

6. Manufacturers shall indicate their name, their registered trade name or registered trade mark, their postal and electronic address and, where different, the postal or electronic address of the single contact point at which they can be contacted. That information shall be placed on the product or, where that is not possible, on its packaging or in a document accompanying the product.

7. Manufacturers shall ensure that their product is accompanied by clear instructions and safety information in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available on the market. That requirement shall not apply where the product can be used safely and as intended by the manufacturer without such instructions and safety information.


You should communicate the product’s safe use and disposal by providing warning labels, user instructions, and safety information for your products.

However, keep in mind that warnings and instructions are never a substitute for basic product safety. You can’t make a product “safe” just by applying a warning label.

Technical documentation

Article 9 requires the provision of technical documentation, which includes the following elements:

  • General product description
  • Essential characteristics for determining the product’s safety
  • Risk analysis
  • Solutions to reduce or eliminate these risks
  • Outcome of reports on tests conducted
  • The list of any relevant European standards applied

The information in the technical documentation should reflect the product’s complexity and potential identified risks. It is also possible that national authorities set “higher” standards for children’s products.

Product tests

It is necessary to test children’s products to ensure their compliance with relevant standards. According to Article 9, the technical documentation should include test reports, and you should state which European standards were adhered to.

Here are examples of companies that offer testing for children’s products:

REACH

The REACH Regulation establishes restrictions for chemicals and heavy metals in consumer products sold in the EU. There are, for example, limits for lead, cadmium, nickel, phthalates, and other substances.

Children’s articles are subject to additional specific requirements, such as the following for certain phthalates:

Examples (Annex XVII)

51.

Bis(2-ethylhexyl) phthalate (DEHP)

CAS No. 117-81-7

EC No. 204-211-0

Dibutyl phthalate (DBP)

CAS No. 84-74-2

EC No. 201-557-4

Benzyl butyl phthalate (BBP)

CAS No. 85-68-7

EC No. 201-622-7

Diisobutyl phthalate (DIBP)

CAS No. 84-69-5

EC No. 201-553-2

1. Shall not be used as substances or in mixtures, individually or in any combination of the phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material, in toys and childcare articles.

2. Shall not be placed on the market in toys or childcare articles, individually or in any combination of the first three phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material.

In addition, DIBP shall not be placed on the market after 7 July 2020 in toys or childcare articles, individually or in any combination with the first three phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material.

3. Shall not be placed on the market after 7 July 2020 in articles, individually or in any combination of the phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material in the article.

[…]

The phthalates, which are endocrine disruptors, are subject to the restrictions mentioned above. However, keep in mind that other restrictions also apply, even if they do not mention childcare-related items.

How can I determine which substances require testing?

Our recommendation is to let a testing lab make that determination. You must, however, clearly communicate the product’s function, target market, and materials used.

Food contact materials

Additional requirements for substances apply to baby bottles, bowls, and other products that come into contact with food and drink. The following is a summary of several food contact material regulations that may apply, depending on the material used:

  • Teats and Soothers Directive 93/11/EEC
  • EU Food Contact Materials Framework Regulation (EC) 1935/2004
  • Good Manufacturing Practice for FCM Regulation (EC) 2023/2006
  • Plastic FCM Regulation (EU) 10/2011
  • Restriction of Use of Certain Epoxy Derivatives in FCM Regulation (EC) 1895/2005
  • Recycled Plastic FCM Regulation (EU) 2022/1616
  • Ceramic FCM Directive 84/500/EEC
  • Active and Intelligent FCM Regulation (EC) 450/2009
  • Regenerated Cellulose Film FCM Directive 2007/42/EC
  • Use of Bisphenol A in Varnishes and Coatings Regulation (EU) 2018/213
  • Polyamide and Melamine Plastic Kitchenware from China or Hong Kong SAR (China) Regulation (EU) 284/2011

The above regulations may also require you to provide documentation, labelling, and lab testing.

How do I know if a product for children is safe?

As mentioned earlier, the product should carry visible traceability labelling. Additionally, the importer or manufacturer should provide test reports proving compliance with chemical and physical safety requirements. If they cannot provide the test reports, there wouldn’t be evidence to claim that the product is safe.

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    Disclaimer: The Site cannot and does not contain legal advice. The legal information is provided for general informational and educational purposes only and is not a substitute for professional advice. Accordingly, before taking any actions based upon such information, we encourage you to consult with the appropriate professionals. We do not provide any kind of legal advice. THE USE OR RELIANCE OF ANY INFORMATION CONTAINED ON THE SITE IS SOLELY AT YOUR OWN RISK.

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    Sources: Our articles are written in part based on publicly available information, and our own practical experience relating to product compliance. These are some of the primary sources we use:

    • ec.europa.eu
    • echa.europa.eu
    • ecfr.gov
    • cpsc.gov
    • ftc.gov
    • fcc.gov
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