Guide to Compliance with EU REACH Regulation for Toys
Navigating the complexities of the REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation is crucial for ensuring that toy products meet EU regulations and safeguard consumer health.
This article provides a straightforward guide to understanding the impact of REACH on toys, detailing compliance responsibilities and essential requirements. By the end, you will be equipped with the knowledge to confidently manage and implement REACH compliance in your operations.
What Is the REACH Regulation?
The REACH Regulation (EC 1907/2006) ensures that chemicals used in products, including toys, are safe for human health and the environment. It requires manufacturers and importers to assess and manage the risks posed by chemicals and to provide safety information to their users.
Noncompliance with REACH can lead to significant consequences, including financial penalties and legal actions. For toy manufacturers, this can also result in recalls and damage to your company's reputation, thereby destroying consumer trust and impacting market presence.
Read more: REACH Compliance Requirements: What the EU’s REACH Regulation Means for Your Business
Who Is Responsible for REACH Compliance in the Toy Industry?
In the toy industry, the responsibility for ensuring REACH compliance primarily lies with manufacturers and importers within the European Economic Area (EEA). This includes companies that produce or import toys or their chemical components into the EU.
Additionally, downstream users who incorporate these chemicals into their toys during manufacturing must also ensure compliance. Distributors, while not directly responsible for registration under REACH, must ensure that the toys they sell comply with all REACH regulations. This holistic approach ensures that every entity involved in the lifecycle of a toy shares in the responsibility of safeguarding consumer health and environmental standards.
Toy Products Restricted under REACH
All products sold in the EU must comply with the REACH regulation. Toy products may fall into several categories, each with specific compliance considerations:
Articles: An object that is given a special shape, surface, or design during production, which determines its function to a greater degree than does its chemical composition.
Example in Toys: Each individual discrete component of a toy qualifies as an article. For instance, a wheel, a doll’s head, and the plush covering of a soft toy are all considered articles. Packaging used for toys is also categorized as an article under REACH.
Materials: Materials refer to the substances and mixtures from which toy articles are made. Under REACH, materials are assessed to ensure they do not contain restricted substances above allowable limits.
Example in Toys: Materials used in toys include plastics, textiles, and metals. For example, the plastic used in a toy car or the fabric of a teddy bear must comply with REACH restrictions related to the chemical components that make up these materials.
Substances: A substance is typically identified by a single CAS number (Chemical Abstracts Service number), which is a unique numerical identifier assigned to every chemical substance described in the open scientific literature. It is a chemical element and its compounds in the natural state or obtained by any manufacturing process. This includes any additive necessary to preserve its stability and any impurity deriving from the process used but excludes any solvent which may be separated without affecting the stability of the substance or changing its composition.
Example in Toys: Substances in toys can include chemicals used in the manufacturing of the toys such as colorants in plastics or adhesives used in assembly. Each substance, like the dyes used for coloring a toy, needs to be registered if manufactured or imported above one tonne per year. Read more: An Overview of REACH SVHCs (Substances of Very High Concern): Understanding SVHCs and Compliance
Chemicals in Toys Restricted under REACH
Annex XVII of REACH imposes specific restrictions on substances, many of which are used in toys. Substances restricted under this regulation are used in various conditions, including mixtures or articles, specific materials, or applications, and are often banned or limited for manufacture and market placement in the EU.
Here are some examples of substances that are restricted under REACH commonly found in toys. These chemicals are restricted in all articles:
Benzene (CAS No. 71-43-2): Benzene is restricted due to its high toxicity.
Cadmium and its compounds (CAS No. 7440-43-9): Cadmium is severely restricted due to its toxicity and environmental impact.
Phthalates such as:
Bis(2-ethylhexyl) phthalate (DEHP, CAS No. 117-81-7)
Dibutyl phthalate (DBP, CAS No. 84-74-2)
Benzyl butyl phthalate (BBP, CAS No. 85-68-7)
Di-isononyl phthalate (DINP, CAS Nos. 28553-12-0 / 68515-48-0)
Di-isodecyl phthalate (DIDP, CAS Nos. 26761-40-0 / 68515-49-1)
Di-n-octyl phthalate (DNOP, CAS No. 117-84-0)
These are restricted due to their potential health effects on reproductive systems.
Polycyclic-aromatic hydrocarbons (PAHs) such as:
Benzo[a]pyrene (BaP, CAS No. 50-32-8)
Benzo[e]pyrene (BeP, CAS No. 192-97-2)
Benzo[a]anthracene (BaA, CAS No. 56-55-3)
Chrysen (CHR, CAS No. 218-01-9)
PAHs are restricted because of their carcinogenic nature.
And many more. This list is not exhaustive. For a full list of restricted substances under Annex XVII, see the European Chemicals Agency (ECHA) website.
How to Ensure REACH Compliance for Toy Products
Ensuring compliance with REACH involves a systematic approach to managing the chemicals used in toy products. Here’s a structured process to help you achieve compliance:
Identify the Toy Components: Determine whether each part of the toy is an article, a mixture, or a substance. Each part must be assessed separately as the requirements may vary. For example, for a toy car, separate assessments might be needed for the plastic body (article), the paint (mixture), and any adhesives used (substances).
Consult the Relevant Tables: Use the list of restricted substances in Annex XVII. Check each component against these restrictions to ensure no component contains any prohibited substances above the specified limits.
Document Compliance: Keep detailed records of all assessments, including the sources of materials and chemicals, safety data sheets, and compliance checks with the relevant REACH entries. We recommend maintaining a compliance file for each toy model that includes supplier certifications, test results, and compliance statements for all materials and substances used.
Regularly Review and Update Compliance Status: Periodically review the compliance status of toys against REACH as new entries may be added to the list of restricted substances or existing regulations may be updated. We recommend scheduling annual reviews of compliance documentation and stay updated with any changes in REACH regulations through resources like the ECHA website.
Engage with Qualified Experts: Consult with REACH compliance specialists and lab testing experts like QIMA, especially for complex products or when new materials are introduced to the toy manufacturing process. With QIMA, you’ll have access to REACH experts to review the chemical management processes and provide guidance on complex cases like imported materials or newly developed substances.
Assess Compliance Requirements of Other Directives: Ensure that in addition to REACH, compliance with other relevant directives such as the Toy Safety Directive and its associated chemical standards is verified. For some product types, like electronics, compliance with other standards, like RoHS, must also be ensured.
Lab Testing for Compliance
Laboratory toy testing ensures that toys meet the rigorous requirements set by REACH and other toy safety regulations. With QIMA’s laboratory and regulatory experts, you can ensure that your products meet regulatory compliance and uphold the quality and safety levels expected in global markets like the EU.
We offer specific REACH testing for restricted chemicals that are most likely to be found in your product, or generalized lab testing for all restricted substances. We can help you determine the best testing protocol for you to ensure compliance.
Contact us to learn more about our toy testing services, or book a test today.
Related Articles
