• Baby Pacifier Standards & Regulations in the European Union

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    Baby pacifier

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    Baby pacifiers are for obvious reasons subject to strict safety standards and substance rest restrictions. In this guide, we explain what importers and manufacturers must know about general safety requirements, EN standards, REACH, lab testing, and much more.

    We also explain why you should not assume that pacifiers manufactured outside the EU are designed to comply with European Union safety requirements in mind.

    General Product Safety Directive (GPSD)

    The General Product Safety Directive (or GPSD) aims at ensuring the safety of consumer products placed in the EU market – including, but not limited to, baby pacifiers.

    The GPSD sets out the general principles and regulatory framework that importers and manufacturers must comply with, while EN standards set technical requirements, testing methods, warning labels, and other product-specific requirements.

    In short, GPSD states that all products must be safe – regardless of whether or not product-specific safety standards exist. However, there are standards in place for this specific product category.

    GPSD Requirements Overview

    • EN 1400 – Child use and care articles. Soothers for babies and young children
    • EN 12586 – Child use and care articles. Soother holder
    • Risk Assessment Report
    • User Manual
    • Technical File
    • Test Report
    • Traceability information

    EN 1400 – Child use and care articles. Soothers for babies and young children

    EN 1400 provides requirements for babies and young children’s soothers. The standard is divided into three parts:

    • General safety requirements
    • Mechanical requirements
    • Chemical requirements

    Scope

    Specifically, EN 1400 covers the following requirements:

    • Safety measures
    • Dangerous materials
    • Chemical hazards
    • Mechanical hazards
    • Performance testing
    • Instruction for use
    • Marking
    • Packaging

    The standard also applies to products that resemble or function as a pacifier, or soother, even if the product is marketed with different functions. However, this standard is not applicable to feeding teats, for which importers and manufacturers should refer to EN 14350 standard instead.

    EN 12586 – Child use and care article – Soother holder

    EN 12586 mainly focuses on potential chemical hazards and strangulation hazards caused by pacifier holders that are too long.

    Scope

    The standard covers the following aspects:

    • Material restrictions
    • Safety measures
    • Mechanical testing
    • Chemical testing
    • Instruction for use
    • Packaging
    • Dimensional measurement

    Design or Compliance

    EN 1400 and EN 12586 cover mechanical properties that directly affect both external and internal product design elements. It’s therefore essential that your product designer has a throughuíut understanding of the practical aspects of all applicable pacifier standards.

    Otherwise, you run the risk of producing a pacifier design that is inherently non-compliant by design. As is often the case, ensuring product compliance starts at the drawing board.

    Risk Assessment Report

    A risk assessment report aims at describing the type of hazards that might be caused by the product – and the course of action taken by the seller in case something goes wrong. In the case of a pacifier, it might include the following:

    a. Chemical hazards, due to excessive migration of dangerous chemicals

    b. Strangulation hazards, due to a pacifier’s holder that is too long

    Importers and manufacturers should provide this document to the authorities in the case of safety issues, or recalls.

    User Instructions

    User instructions provide information such as the following:

    • Company information
    • Intended use
    • Cleaning instructions
    • Disposal instructions
    • List of components
    • Warning labels

    Technical File

    Even though the GPSD doesn’t explicitly require a technical file, you can still create one to prove the product’s compliance, especially if such proof is requested by the relevant authorities.

    A technical file often includes information such as:

    • Bill of Materials
    • Product design drawing
    • List of components and materials
    • Risk assessment
    • Test reports

    You may already have most of these documents as part of your product specification.

    Test Report

    Importers and manufacturers can contact a reputable lab testing to test their products against relevant standards, such as EN 1400 or EN 12586. If the product passes the test, they can then use the test report provided by the lab testing to prove compliance against one or more standards.

    Toy Soother Holder: Toy Safety Directive

    The Toy Safety Directive regulates toys and products with “play value” placed in the EU market. Thus, pacifier holders that have a “play value” fall under the scope of the directive.

    Given the fact that a pacifier is not a toy, it might sometimes be might be difficult for importers or manufacturers to determine whether their pacifier holders have “play value”. For this reason, the European Commission provides a Guidance Document that explains how to classify pacifier (or soother) holders.

    Here are some examples that are taken from the above-mentioned guidance document:

    a. Functional soother holders with no additional parts are deemed to do not have any play value

    b. Basic soother holders made of silicone beads are deemed to do not have any play value

    c. Soother holders with a clip designed with fabric owl (similar to a plush toy) are deemed to have play value

    d. Soother holders with wooden beads in different colors and shapes (cars, flowers) are deemed to have play value

    You can refer to the sample pictures and description provided in the document to evaluate whether your products have play value, in which case they must comply with the requirements of the Toy Safety Directive:

    Toy Safety Directive Requirements Summary

    • EN 71-1: Mechanical and physical properties
    • EN 71-3: Specification for migration of certain elements
    • Declaration of Conformity (DoC)
    • Technical File
    • User Instructions
    • Test Report
    • CE Mark
    • Traceability information

    EN 71-1: Mechanical and physical properties

    EN71-1 specifies requirements and methods of tests for mechanical and physical properties of toys, including pacifier holders with play value. As pacifier holders might be attached with cords or drawstrings, safety requirements for avoiding strangulation hazards associated with the product are highly relevant.

    In addition, this standard provides guidelines on warning labels depending on different physical and mechanical properties. Here are some warning examples:

    a. “Warning. Strangulation hazard. Long cord. Adult supervision required.”

    b. “Warning. Long cable. Strangulation hazard.”

    EN 71-3: Specification for migration of certain elements

    EN 71-3 specifies the chemical testing requirement for toys, including pacifier holders with play value. The standard sets out the migration limits of certain harmful substances such as heavy metals and other pollutants. Here are some examples of restricted substances:

    • Cadmium
    • Mercury
    • Nickel
    • Lead

    The limitation applies to all accessible parts of the pacifier holder such as coating or surface paint.

    Declaration of Conformity (DoC)

    The Declaration of Conformity (DoC) is a self-issued document that demonstrates product compliance of a given product with one or more CE directives. A DoC should include information such as:

    • Manufacturer/importer’s information
    • Product SKU or batch number
    • Product description
    • List of applicable directives (ie. Toy Safety Directive)
    • List of applicable safety standards (ie. EN 71-1, EN 71-3)
    • Supporting test reports

    Technical File

    A technical file is a set of product documents that provide in-depth details such as design drawings and bills of materials, including the following information:

    • Manufacturer’s identification
    • Product design drawing
    • List of components and materials
    • Safety assessment
    • Declaration of Conformity
    • Test reports

    User Instructions

    User instructions are intended to provide assistance and guidance to the end-user. In this case, for obvious reasons, the instructions should be written for parents or other caregivers. In general, they cover the following information such as:

    • Product description
    • Technical data
    • Safety instruction
    • Warnings and precautions
    • Compliance statements
    • Compliance marks (e.g. CE mark)

    Test Report

    It is the importer’s responsibility to ensure that their test reports are sufficient to demonstrate compliance with all applicable requirements. Third-party lab testing is often the only way to ensure your product compliance with technical requirements such as substance restrictions or physical properties requirements.

    CE Mark

    CE Mark

    The Toy Safety Directive is a ‘CE directive’, and as such importers and manufacturers must attach the CE marking to the product or, when not possible, to the packaging. You can download the standard CE marking in different formats (e.g png, jpg, ai) on the EU official website.

    REACH

    REACH restricts chemicals, heavy metals, and pollutants in consumer products, including baby pacifiers. Therefore importers and manufacturers should ensure that their products do not contain excessive amounts of restricted substances such as the following:

    • Phthalates
    • Cadmium
    • Lead
    • Mercury

    REACH provides a list of restricted substances under Annex XVII. However, most importers or manufacturers don’t have the technical ability to assess REACH’s compliance, as it requires a high level of expertise and laboratory equipment. Instead, they can contact a testing company to verify if their product complies with the regulation’s requirements.

    Traceability

    Both the GPSD and the Toy Safety Directive requires that the product or its packaging includes a traceability label containing information such as:

    • Company name
    • Company address
    • Company contact information
    • Product SKU or batch ID

    Amazon Requirements

    Before selling products on Amazon, you should always evaluate confirm if the platform has stricter requirements than the EU, which might be the case for some products.

    Even in the case where Amazon doesn’t have any additional constraints, it still requires that you ensure that the pacifiers comply with all applicable regulations in the EU, and submit the relevant information for each product SKU, such as:

    • Importers and manufacturers information
    • Product description
    • Declaration of Conformity
    • Test reports
    • Warning label files
    • Other labeling files

    Note that Amazon might require compliance documents at any moment, not just when you are listing your product. If your product is already listed and you don’t have all the required documents, they might give you a deadline to comply, or just delist your products.

    Lab Testing

    Lab testing is necessary to verify that your pacifier is compliant with all applicable standards and substance restrictions. When it comes to pacifiers, it’s necessary to test both the general safety of the pacifier construction – and the substances in the silicone nipple and the shield.

    Mechanical/Physical Properties Testing

    1. Is the internal and external design compliant with applicable safety standards?

    2. Is the material durable?

    3. Is there any risk of small parts falling off?

    Substance Testing

    1. Heavy metals testing

    2. Phthalates testing

    3. Other substance tests

    Compliance Risks

    Baby pacifiers manufactured outside the European Union are not by default designed to comply with EU safety standards. Hence, some products don’t reach the mechanical design requirements – and are therefore inherently non-compliant by design.

    Further,  the silicone nipple and shield material may also contain excessive amounts of heavy metals, phthalates, and other restricted substances.

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    Disclaimer: The content on this website is provided for general information only. The content includes summaries written by our team members based on publicly available information about product safety standards, labeling, documentation, testing, processes, and other product compliance related topics. However, we don’t guarantee that we cover every single relevant regulation/standard/requirement, or that the information is free from errors, or covering every single scenario and exemption. We do make mistakes from time to time. We never provide legal advice of any sort.

    Changes/Updates: Product standards and substance restrictions are subject to frequent updates and changes. In addition, new regulations, standards, and/or requirements may also become effective at any time. We don’t update our articles whenever new standards/regulations/rules are added or changed. We recommend that you consult a lab testing company or other professional to get the latest information about mandatory standards/regulations in your market, country, or state. Lab testing companies generally stay up to date on new and updated standards and regulations.

    National/State-Level Standards/Regulations: Many articles don't cover all European national and US state standards, regulations, and requirements. We recommend that you consult a testing company or other professional to confirm all relevant (and current) national/state level standards and regulations.
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