Custom Silicone Baby Products Manufacturer | OEM/ODM
EU & UK Compliance Service

Baby Products
EU & UK Compliance.

YMS provides end-to-end compliance support for silicone baby products entering the European Union and United Kingdom markets -- from material declarations to CE/UKCA documentation and lab-tested safety reports.

Start Compliance Request
CE
UKCA
LFGB
EN71
EU/UK
Standards
10 Steps

Full Compliance
Workflow

From material sourcing to final test reports -- managed in one place.

EU

CE / EN71 / REACH

UK

UKCA / BS EN71

100%
Compliant
Step 01

Product Category & Intended Use.

The first step of EU/UK compliance begins by precisely confirming the product category and intended use. This determines which directives, standards, and tests will apply.

Food Contact Items

  • ✦ Bottles, nipples, pacifiers
  • ✦ Plates, bowls, cups
  • ✦ Spoons, forks, straws
  • ✦ EU 10/2011 · Framework 1935/2004

Toys & Teethers

  • ✦ Teething rings & chewables
  • ✦ Rattles & grasping balls
  • ✦ Bath toys
  • ✦ Directive 2009/48/EC · EN71

Childcare Articles

Bibs, bath brushes, toothbrushes and other baby care items regulated under GPSR and EN 14350 / EN 1400.

EN 14350 EN 1400 GPSR
Silicone raw materials and verified supplier documents
Step 02

Materials & Supplier Documentation.

We prepare complete material declarations and supplier chains to meet REACH, FCM, and traceability requirements set by EU and UK authorities.

01

Material Composition Sheet

Full disclosure of silicone grade, pigments, and additives -- including CAS numbers.

02

Supplier Declarations (DoC)

Signed REACH, RoHS, FDA, and food contact statements from upstream raw material partners.

03

Batch Traceability Records

Lot-level traceability from raw silicone to finished product packaging.

Step 03

Identifying the Right Tests.

We help you decode EU and UK testing requirements and shortlist the exact standards your product must comply with -- avoiding costly over-testing or missing certifications.

EN 71

Toy safety: mechanical, physical, flammability & chemical migration.

EN 14350

Drinking equipment safety requirements for infants.

EN 1400

Soothers / pacifiers for babies and young children.

REACH SVHC

Substances of Very High Concern screening (240+ substances).

FCM 10/2011

Plastic materials in contact with food -- specific migration limits.

BfR XV

German recommendation for silicone food-contact articles.

LFGB §30/31

German food safety law for consumer goods.

UKCA

UK Conformity Assessed -- mandatory marking for Great Britain.

Step 04

Sample Prep & Lab Coordination.

We handle sample preparation, lab appointment, and submission logistics -- working with accredited third-party labs (SGS, Intertek, TÜV, Bureau Veritas) to ensure smooth and efficient testing.

Avg. turnaround: 10-15 business days
01

Mass-Production Sample Pick

Random pick from the actual production batch to ensure test results reflect real-world shipment quality.

02

Pre-Lab Visual Check

In-house pre-check on dimensions, markings, and packaging integrity before lab submission.

03

Lab Booking & Submission

Direct communication with accredited labs; priority slots for urgent timelines.

04

Test Follow-up & Issue Resolution

We follow the testing progress daily and immediately address any failure through re-formulation or re-testing.

Step 05

Technical Documentation.

A complete Technical File (TF) is required under EU Toy Safety Directive and UKCA. YMS prepares all engineering, process, and safety documentation ready for customs and authority inspection.

Product Specification Sheet

Dimensions, tolerances, weight, material composition and intended user age.

Risk Assessment Report

Mechanical, chemical, flammability and small-parts risk evaluation per Directive 2009/48/EC.

Technical Drawings

2D/3D CAD files, exploded views and bill of materials.

Declaration of Conformity

Signed DoC referencing applicable EU directives and harmonized standards.

Manufacturing Process

Flow charts covering injection, curing, post-processing, and inspection.

Confidential Archive

All technical files are retained for a minimum of 10 years under EU/UK regulatory requirements.

Step 06

Labeling & Packaging Compliance.

Correct labeling is often the number one reason for customs rejection. YMS supports artwork review, warning statements, and multilingual compliance for every target country.

CE / UKCA Mark Placement +
Minimum size, visibility, and permanence of CE/UKCA marks on product or packaging.
Warning Statements & Age Grading +
Multilingual warnings (DE/FR/ES/IT), 0-3M age labels, choking hazard icons.
Importer & Responsible Person +
Mandatory EU importer address (EC REP) and UK Responsible Person (UKRP) under GPSR.
Recycling & Packaging Symbols +
Triman, Green Dot, resin identification codes and PPWR compliance (EU Packaging Regulation 2025).
Compliant baby product packaging with CE and UKCA labels
Step 07

Test Reports & Archive.

All test reports are organized, versioned, and archived in a secure digital system -- accessible to you anytime for customs, Amazon, or retail audit purposes.

Document Type Retention
Chemical Migration Report 10 years
Mechanical & Physical Report 10 years
Flammability Test 10 years
Chemical Elements (Migration) 10 years
REACH SVHC Screening Permanent
Declaration of Conformity 10 years
Step 08

Confirm Your Sales Market.

Compliance scope depends on where your product will be sold. Confirming your target markets upfront saves cost and prevents duplicate testing -- EU, UK, or both.

EU

European Union (27 countries)

CE marking · Multilingual labels · EU importer required

UK

United Kingdom (GB)

UKCA mark · UK Responsible Person · English labels

EU+UK

Dual Market Coverage

Shared testing scope · Separate marks & labels · Best cost efficiency

Submit Your Request

Start Your EU/UK Compliance Journey.

Share your product details and target markets -- our compliance specialists will respond within 24 hours with a tailored roadmap and quotation.

Target Market *

By submitting, you agree your information is used solely for compliance consultation. We respond within 24 business hours.