Guide to international certification and compliance requirements for export of maternal and child products

I. Certification requirements for major international markets

  1. EU market
    CE certification: mandatory certification, must comply with the EU Toy Safety Directive (2009/48/EC) and the General Product Safety Directive (2001/95/EC)

EN71 standard: Toy safety standard (Parts 1-3)

REACH Regulation: Registration, Evaluation, Authorization and Restriction of Chemicals

Food Contact Materials Regulation (EC) No 1935/2004: Applicable to baby bottles, tableware, etc.

OEKO-TEX® Standard 100: Testing for hazardous substances in textiles (not mandatory but recommended)

  1. US market
    CPSC certification: Consumer Product Safety Commission supervision, must comply with 16 CFR standards

ASTM F963: Toy safety standard

FDA certification: Food contact materials (such as baby bottles, tableware) must comply with 21 CFR standard

CPSIA: Consumer Product Safety Improvement Act, lead and phthalate restrictions

JPMA certification: voluntary certification of the Juvenile Products Manufacturers Association (such as strollers, safety seats)

  1. Japanese market
    ST Mark certification: toy safety standard

Food Sanitation Law: Applicable to food contact products

PSC mark: specific product safety certification

  1. Australia/New Zealand market
    AS/NZS ISO 8124: Toy safety standard

ACCC supervision: Australian Competition and Consumer Commission requirements

II. Special requirements for product classification

  1. Baby food contact products
    EU: Comply with (EC) No 1935/2004, specific migration limit (SML)

USA: FDA 21 CFR 170-189

China: GB 4806 National Food Safety Standard

  1. Baby textiles
    OEKO-TEX® Standard 100 Class I (for babies only)

EU: Banned azo dyes (2002/61/EC)

USA: Flammability standards (16 CFR 1610)

  1. Baby care products
    Electric heating products: need to comply with the Low Voltage Directive (LVD) and Electromagnetic Compatibility (EMC) requirements

Cleaning products: EU Cosmetics Regulation (EC) No 1223/2009

  1. Children’s toys
    Small parts warning: Applicable to products for children under 3 years old

Magnetic requirements: ASTM F963 and EN71-1 have special provisions

III. Compliance process suggestions
Product classification: clarify the category to which the product belongs and the applicable regulations

Standard identification: determine all applicable standards for the target market

Test preparation:

Select an accredited laboratory (such as SGS, TÜV, Intertek)

Prepare enough samples

Document preparation:

Technical documents (including design drawings, bill of materials)

Risk assessment report

Declaration of Conformity (DoC)

Certification application: submit an application to a designated agency

Label review: ensure compliance with the labeling requirements of the target market

Continuous compliance: establish a change management and market supervision system

IV. Common challenges and solutions
Multi-country regulatory differences: establish a product compliance matrix, country by country Comparison requirements

Material compliance: Establish a list of qualified suppliers and require material compliance certificates

Standard updates: Subscribe to standard update services and regularly review product compliance

Cross-border e-commerce: Platform-specific requirements (such as Amazon CPC certificates)

Cost control: Rationally plan the certification sequence and use mutual recognition agreements

V. Latest trends
Sustainable development requirements: EU Green New Deal affects product design

Digital Product Passport (DPP): The EU’s upcoming digital labeling system

Microplastic restrictions: The EU has imposed restrictions on microplastics in certain products

PFAS restrictions: Stricter control of perfluorinated and polyfluoroalkyl substances

It is recommended to consult a professional certification body before exporting to obtain the latest compliance advice for specific products and target markets. Different product categories (such as toys, textiles, and food contact materials) may have additional special requirements.

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