Compliance Checklist

CE Marking
Baby & Toddler
Germany 🇩🇪

Complete compliance checklist for CE marking of baby products on the German market. Covers EN 12790 (recliners), EN 1888 (strollers), EN 716 (cots), EN 14988 (highchairs), and particularly strict requirements for products for children under 3 years.

Overview

Baby products are subject to the strictest safety requirements of all consumer product categories in the EU. CE marking is mandatory for most baby products and requires compliance with specific harmonised EN standards. For the German market, additional requirements under the Product Safety Act (ProdSG) and the 2nd ProdSV (Toy Safety Regulation) for toy-like baby articles apply. Requirements for products for children under 36 months are particularly strict: enhanced mechanical tests, stringent chemical limits, and special warnings. Notified Bodies must be involved in many cases. This checklist guides you through the entire CE marking process for baby products.

Does this apply to my product?

This checklist applies to manufacturers, importers, and distributors selling baby products in Germany. Products covered include: baby bouncers and swings (EN 12790), strollers and buggies (EN 1888), cots and travel cots (EN 716), highchairs (EN 14988), baby carriers and hip seats (EN 13209), playpens (EN 12227), changing mats and tables, and all other products specifically designed for use by or with infants and toddlers under 36 months.

Step-by-Step Guide

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Identify Applicable EU Directives and Harmonised Standards

Determine which EU Directives and harmonised standards apply to your baby product. Most baby products fall under the General Product Safety Directive, many additionally under the Toy Safety Directive 2009/48/EC. The specific EN standard must be identified for each product.

Estimated time: 1-3 Tage

Determine product category and corresponding EN standardRequired

Assign your product to the correct EN standard: EN 12790 for baby bouncers and seats, EN 1888 for strollers and buggies (Parts 1-3), EN 716 for cots (Parts 1-2), EN 14988 for highchairs, EN 13209 for baby carriers (Parts 1-2), EN 12227 for playpens, EN 1466 for carrycots/Moses baskets. For products that also serve as toys, EN 71 applies additionally.

Copy of the relevant EN standard(s)

Check Toy Safety Directive 2009/48/EC applicabilityRequired

Check whether your baby product could also be classified as a toy. The Toy Safety Directive defines toys as products designed or intended for use in play by children under 14. Baby rattles, teething rings, mobiles, play arches, and similar products fall under the Toy Safety Directive with additional requirements for EN 71 (Parts 1-14) and strict chemical limits.

Assessment of toy classification with justification

Verify Product Design and Construction per EN Standards

Ensure the product design meets all requirements of the applicable EN standards. For baby products, mechanical, physical, and chemical safety requirements are particularly strict.

Estimated time: 1-2 Wochen

Assess mechanical and physical safetyRequired

Check mechanical safety requirements: entrapment protection (finger pinch points, head/body entrapment), stability and tip-over protection, strength of closures and harness systems, safety of folding/collapsing mechanisms, no swallowable small parts (small parts cylinder test per EN 71-1 for under-36-months products), no sharp edges or points.

Design review protocol referencing EN standard requirements

Assess chemical safety requirementsRequired

Baby products are subject to the strictest chemical limits: migration of heavy metals (EN 71-3), phthalates (max. 0.1% for DEHP, DBP, BBP, DIBP), formaldehyde (max. 16 mg/kg for textile parts for under-3-year-olds per OEKO-TEX Standard 100 Class I), BPA restrictions, AZO dyes, and REACH SVHCs. For products that can be mouthed (teething rings, rattles), the migration limits of EN 71-3 additionally apply.

Chemical test reports (heavy metal migration, phthalates, formaldehyde, BPA)

Assess suffocation and strangulation riskRequired

Conduct a specific assessment of suffocation and strangulation risks: no cords/strings longer than 220 mm in the head/neck area, no loops with circumference greater than 360 mm, packaging films at least 0.038 mm thick or with ventilation holes, no detachable fillings (beads, pellets) within reachable proximity.

Suffocation/strangulation risk assessment

Testing by Accredited Laboratory / Notified Body

Have your baby products tested by an accredited laboratory or Notified Body. For many baby products, involvement of a Notified Body is mandatory.

Estimated time: 4-8 Wochen

Engage Notified Body (if required)Required

For products under the Toy Safety Directive 2009/48/EC, an EC type examination (Module B) by a Notified Body is mandatory when no harmonised standard exists or when the product deviates from the standard. For pure childcare articles (strollers, cots, highchairs), conformity assessment can also be done without a Notified Body, but voluntary involvement is strongly recommended.

EC type examination certificate (under Toy Safety Directive)Test reports from the accredited laboratory

Conduct complete testing per applicable EN standardsRequired

Testing must cover all relevant sections of applicable EN standards. For a stroller (EN 1888) this includes e.g.: dynamic durability test (100,000 cycles), static load test, tip-over stability on slopes, harness system strength, folding mechanism safety, entrapment protection, flammability of textiles, and chemical tests. Sample products must be submitted in new condition.

Complete test report referencing all standard sections

Create Technical Documentation and EU Declaration of Conformity

Create the technical documentation (Technical File) and the EU Declaration of Conformity (DoC) demonstrating that your baby product meets all applicable requirements.

Estimated time: 3-5 Tage

Compile technical documentation (Technical File)Required

The technical documentation must contain: general product description, design and construction drawings, material list with suppliers, applied harmonised standards, risk assessment, test reports, EC type examination certificate (if applicable), manufacturing process description, quality control procedures, and the EU Declaration of Conformity. Documentation must be kept for 10 years.

Complete Technical File

Issue EU Declaration of Conformity (DoC)Required

Create the EU Declaration of Conformity with the following mandatory information: product identification (model, type, batch/serial number), manufacturer name and address, authorized representative name and address (if applicable), statement of sole responsibility, applied directives and standards, reference to Notified Body certificate (if applicable), date and signature.

EU Declaration of Conformity (signed)

Apply CE Marking and Mandatory Labelling

Apply the CE marking and all other mandatory markings correctly on the baby product. Labelling requirements for baby products are particularly extensive.

Estimated time: 2-4 Tage

Apply CE mark correctlyRequired

The CE mark must be visible, legible, and indelibly affixed to the product, packaging, or an accompanying document. The minimum height is 5 mm. For toy products, the Notified Body number must additionally appear next to the CE mark. The proportions of the CE mark must correspond to the official template.

Photo of the applied CE mark on the product

Apply age and safety warningsRequired

Apply all required warnings in German: age warning (e.g., 'Not suitable for children under 36 months' with warning symbol), specific hazard warnings (choking hazard, strangulation risk, tip-over risk), maximum weight/size restrictions, usage instructions with assembly and use guidance, and the warning 'ACHTUNG' in bold before each safety warning.

Label design with all warnings in GermanUser manual in German

Amazon Listing and Marketplace Compliance

Set up your Amazon listing for baby products in full compliance. Amazon has particularly strict requirements for the Baby category and conducts regular compliance checks.

Estimated time: 1-3 Tage

Obtain Amazon Baby category approvalRequired

The Baby category on Amazon is frequently restricted (Gated Category). Apply for approval by submitting: CE Declaration of Conformity, test reports, product images with CE marking and warnings. Amazon may additionally require invoices from authorized suppliers.

Amazon category approval confirmation

Correctly complete all GPSR and CE fields in the listingRequired

Complete all Amazon mandatory fields: Responsible Person data, confirm CE marking, age recommendation, safety warnings in German, weight limit, applied standards. Ensure at least one listing image shows the CE marking and warnings.

Fully completed Amazon listing with all mandatory fields

Common Mistakes to Avoid

Assessing the product only under general product safety, not under the specific EN standard

Consequence: Harmonised EN standards for baby products contain specific safety requirements (e.g., entrapment, tip-over stability) that go far beyond general product safety. Without EN standard testing, critical risks are overlooked and the product can be immediately withdrawn during market surveillance checks.

Prevention: Before market entry, identify the exact EN standard for your product and have a complete test performed by an accredited laboratory.

Age warning and choking hazard notice missing or only in English

Consequence: Missing or non-German warnings on baby products are the most common reason for listing suspensions on Amazon.de and regulatory complaints. Without correct warnings, the seller is personally liable in case of accidents.

Prevention: Ensure all warnings are in correct German on the product, packaging, and Amazon listing. Have texts reviewed by a native speaker.

Applying chemical tests with adult limits instead of baby limits

Consequence: Baby products are subject to significantly stricter chemical limits than adult products (e.g., formaldehyde: 16 mg/kg instead of 75 mg/kg). A product meeting adult limits can significantly exceed baby limits. Authorities specifically test against baby-specific limits.

Prevention: Explicitly instruct the laboratory to test against baby/toddler limits. Reference OEKO-TEX Standard 100 Class I as a benchmark.

Applying CE marking without complete technical documentation in place

Consequence: CE marking without proper conformity assessment is an administrative offense and can be criminally prosecuted. Fines can reach up to 100,000 EUR. Additionally, product recalls, listing suspensions, and reputational damage are possible.

Prevention: Only apply CE marking when technical documentation is complete, all tests have been passed, and the EU Declaration of Conformity has been signed.

Not assessing and testing all product variants individually

Consequence: Different variants (e.g., different colours, sizes, or materials) can have different risk profiles. A variant with different textiles can fail the flammability test, a different colour can yield different chemical results. Each variant must be assessed individually.

Prevention: Create a variant matrix and assess which variants require separate tests. At minimum, chemical tests must be conducted per colour/material.

Frequently Asked Questions

Q1Do all baby products require CE marking?

Not all, but most. Products falling under the Toy Safety Directive (rattles, teething rings, mobiles, play arches) mandatorily require CE marking. Pure childcare articles (strollers, cots, highchairs) do not legally require CE marking but must still comply with applicable EN standards. In practice, Amazon and consumers expect CE marking even for these products.

Q2What special requirements apply to products for children under 36 months?

For under-36-months products: enhanced small parts testing (all detachable parts must be larger than the small parts cylinder), stricter chemical limits (especially migration), increased flammability requirements, special warnings ('Not suitable for children under 36 months' with symbol), and all materials must be saliva-resistant. These requirements are detailed in EN 71-1, EN 71-2, and EN 71-3.

Q3Can I apply the CE marking myself, or must an external body do it?

As manufacturer or importer, you apply the CE marking yourself. The CE marking is a manufacturer's declaration that the product meets all applicable EU requirements. However, you are responsible for ensuring that the conformity assessment has been fully completed before application. For toys, the Notified Body number must additionally be stated if involved in the conformity assessment.

Q4How often must baby products be retested?

There is no legally mandated retesting frequency. However, new tests are required for: changes to product design, material changes, manufacturing site changes, changes to applied standards, and specific safety indications. Random retesting every 1-2 years and for each new production batch from a new manufacturing period is recommended.

Q5What does CE marking cost for a single baby product?

Total costs vary between 2,000 and 10,000 EUR depending on product complexity. A simple baby product (e.g., teething ring) is at the lower end, a complex product (e.g., stroller with multiple functions) at the upper end. Main cost drivers are laboratory testing and Notified Body involvement. With multiple variants, costs increase due to additional tests.

CE MarkingBaby & ToddlerGermany 🇩🇪