Planning to import or manufacture baby feeding bottles in the European Union? Childcare products, including baby feeding bottles, are strictly regulated. More specifically, baby bottles must both meet strict mechanical safety standards, and food contact material regulations.
In this guide, we cover relevant safety standards, substance restrictions, labelling, documentation, and testing requirements.
In addition, this guide also covers compliance risks that baby feeding bottle importers and manufacturers must be aware of.
Content Overview
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EN 14350 – Child Care Articles – Drinking Equipment
EN 14350 – Child Care Articles – Drinking Equipment covers various types of feeding equipment for infants and other children. More specifically, ensuring compliance requires that the feeding bottle meets certain design and construction criteria, outlined in the standards.
Product scope
This standard covers the following product types:
- Re-usable containers
- Re-usable drinking accessories
- Single-use containers
- Drinking accessories sold with single-use containers
- Single-use feeding teats
- Ready to use feeding teats
It does not apply to:
a. Products designed for specialist clinical medical applications
b. Ceramic drinking equipment
c. Bags meant only for storage purposes
d. Drinking equipment with foods or liquids inside of it when purchased
e. Feeding accessories fixed to drinking equipment
f. Soothers
g. Cutlery and other feeding utensils
Requirements
The standard specifies safety requirements regarding drinking equipment meant for use by children up to 4 years of age, including the following:
- Material requirements
- Construction requirements
- Performance requirements
- Packaging requirements
- Product information requirements
General Product Safety Directive (GPSD)
The General Product Safety Directive (GPSD) establishes safety requirements for consumer products, which include infant products such as baby feeding bottles.
As such, importers and manufacturers of baby feeding bottles should ensure that their products comply with the requirements of the directive before placing them on the EU market. This might include labelling, documentation, and testing requirements.
Harmonised standards
The GPSD lists harmonised standards that cover requirements for specific products. Harmonised standards offer a presumption of conformity with the directive’s requirements. As such, if baby feeding bottles comply with relevant harmonised standards, then one may reasonably assume that they comply with the directive’s technical requirements.
The list of harmonised standards under the GPSD includes “EN 14350-1 – Child use and care articles – Drinking equipment – Part 1: General and mechanical requirements and tests”, which has been superseded by EN 14350.
EN 14350 is expected to be harmonised under the GPSD, even though the CEN-CENELEC’s website doesn’t provide a timeline for its citation on the EU Official Journal.
Notice that compliance with non-harmonised standards is in practice required when there are no harmonised standards in place, or if these do not cover certain safety aspects.
Requirements
Importers and manufacturers should provide the necessary label and documentation to aid product traceability and help minimising risks caused by the product. This might include the following items:
a. Product traceability labelling (e.g., producer and product details)
b. User instructions (e.g., usage or disposal instructions)
c. Relevant test reports
d. Technical file
Use of Bisphenol A in Varnishes and Coatings Regulation (EU) 2018/213
Regulation (EU) 2018/213 is an amendment to the Plastic Food Contact Materials Regulation (EU) 10/2011, and it bans the use of Bisphenol A in:
a. Polycarbonate infant feeding bottles
b. Polycarbonate spill-proof drinking cups or bottles that are intended for infants and young children
Importers and manufacturers should provide evidence (e.g. a test report) that their products comply with relevant requirements in the regulation by drafting a Declaration of Compliance.
Annex I of the regulation contains instructions on how to draft the declaration.
Teats and Soothers Directive 93/11/EEC
Directive 93/11/EEC sets specific requirements concerning the release of N-nitrosamines and N-nitrosatable substances on teats and soothers made of, or containing, elastomer or rubber.
Specifically, the directive sets the following migration limits:
a. N-nitrosamines < 0.01 mg in total release/kg of the parts teats or soothers made of elastomer or rubber
b. N-nitrosatable < 0.1 mg in total release/kg of the parts made of elastomer or rubber
The directive also provide methods to test product against its requirements.
EU Food Contact Materials Framework Regulation (EC) 1935/2004
Regulation EC 1935/2004 sets general requirements for materials meant to come into contact with food and drink manufactured, imported, or sold in the European Union. It mandates importers and manufacturers to ensure that food contact materials (FCM):
a. Do not endanger human health
b. Do not unacceptably alter the food’s composition
c. Do not cause deterioration of the food’s characteristics
Requirements
In order to reach the above goals, the regulation requires importers and manufacturers of FCM to:
a. Make sure that their products adhere to good manufacturing practices
b. Comply with the specific measures listed in Article 5 that concern specific materials used in FCM (e.g., plastic)
c. Affix the labelling information listed in Article 15 to their products and packaging
d. Draft a Declaration of Compliance as required by relevant specific measures
Plastic Food Contact Materials Regulation (EU) 10/2011
Regulation (EU) 10/2011 specifies requirements for the chemical composition of plastic food contact materials such as baby feeding bottles. This includes a list of authorised substances, substance limits, and mandated documentation.
Authorised substances
Annex I of the regulation contains a Union List of authorised substances. These are the only substances that can be intentionally added during the manufacturing process of plastic FCM. The list includes:
- Monomers
- Additives
- Polymer product aids
- Macromolecules
Migration limits
Annex II of the regulation mandates that plastic materials do not release specific substances above set migration limits, including:
- Barium = 1 mg/kg
- Cobalt = 0.05 mg/kg
- Copper = 5 mg/kg
- Iron = 48 mg/kg
- Primary aromatic amines = 0.01 mg/kg
Documentation
Importers and manufacturers are also required to create documentation such as the following:
a. A Declaration of Compliance
b. Supporting documents that might include test results, modelling, and analysis that demonstrates that product’s compliance
Epoxy Derivatives Restriction Regulation (EC) 1895/2005
Regulation (EC) 1895/2005 restricts the usage of certain epoxy derivatives in plastic articles and materials meant to come into contact with food.
Specifically, the regulation restricts the usage of the following substances:
- BADGE and some of its derivatives
- BFDGE
- NOGE
The regulation requires importers and manufacturers to:
a. Adhere to the migration limits in Annex I
b. Drafting a Declaration of Compliance for articles and materials containing BADGE
Food Contact Materials from China or Hong Kong SAR (China) Regulation (EU) 284/2011
Regulation (EU) 284/2011 establishes requirements for importing FCM containing melamine or polyamide to the EU from China or Hong Kong SAR (China) .
The regulation requires the following:
a. Notification of the consignment to competent authorities at points of entry, at least 2 working days before arrival
b. A declaration containing the information listed in the ANNEX of the regulation
c. A lab testing report covering the analysis of primary aromatic amines (for polyamide products) and formaldehyde (for melamine products)
Good Manufacturing Practice for FCM Regulation (EC) No 2023/2006
To comply with applicable regulations and relevant requirements, manufacturers and importers must implement good manufacturing practices (GMP) during every stage of the production process.
The proper implementation of the GMP might involve the implementation of:
a. A quality assurance system (e.g., personnel training, premise organisation)
b. A quality control system to monitor the implementation of the GMP
This must be documented as well.
REACH
REACH regulates chemicals manufactured and imported in the EU that might pose a danger to consumers or the environment. It also regulates articles that might contain such chemicals. Lab testing might be required to ensure that your product, including childcare articles such as baby bottles, do not contain restricted substances above the limit.
SVHC
Substances of Very High Concern (SVHCs) are regulated under REACH because they:
a. Are carcinogenic, mutagenic, or toxic for reproduction (CMR 1 or 2)
b. Are deemed, per REACH Annex III, persistent, bioaccumulative, and toxic (PBT), or
c. May potentially cause endocrine issues
If substances on the SVHC Candidate List exceed a concentration of 0.1% by weight, REACH requires importers and manufacturers to notify:
a. The European Chemicals Agency (ECHA), via the SCIP database
b. Consumers, if they request so
An example of SVHC that might be relevant to baby bottles is Bisphenol A (BPA).
Restricted Substances
Annex XVII to REACH lists substances that are considered to be harmful. Restrictions or prohibitions of these substances might depend on the product type, age group, and other factors.
Importers and manufacturers of products such as baby feeding bottles should comply with Annex XVII requirements. This includes ensuring that the concentration levels of any regulated substances they may use remain under the prescribed limit.
Below we list some examples of restricted substances that may be relevant to baby bottles, including their restriction limits concerning childcare articles:
a. PAH < 0.00005% by weight
b. Phthalates (DEHP, DBP, BBP DIBP, DINP, DIDP, DNOP) < 0.1% by weight
c. Lead and its compounds < 0.05% by weight
National Baby Bottles Regulations
Several European countries have developed regulations restricting the use of Bisphenol A in feeding bottles. Below we list some of these regulations.
France
Law No. 2012-1442 of 24 December 2012 in France prohibits the use of Bisphenol A on food contact packaging and containers, including baby bottles.
Denmark
Denmark’s Statutory Order on food contact materials No. 822 June 26th, 2013 prohibits the use of Bisphenol A in food contact materials designed to be used by children under the age of 3 years old.
Belgium
Belgium’s Act of 4 September 2012 forbids the use of Bisphenol A in food containers intended to be used by children under the age of 3 years old.
Lab Testing
Importers and manufacturers of baby feeding bottles often need to have their products tested to prove that said products comply with relevant requirements, such as substance restrictions under REACH or FCM regulations.
Below we list a few tests that may be relevant to baby feeding bottles:
- Substance limit testing (e.g. REACH phthalates limits)
- Substance migration testing (e.g. FCM substance migration)
- Mechanical tests (e.g. small parts)
When a product passes relevant testing, the test lab issues a test report to the importers and manufacturers evidencing the product’s compliance with the relevant requirements.
Here are a few testing companies that offer testing services for baby feeding bottles:
- SGS
- Intertek
- Eurofins
- QIMA
Compliance Risks
Materials, paints, and coatings used to manufacture baby feeding bottles outside the European Union may contain excessive amounts of restricted chemicals and heavy metals. Keep in mind that feeding bottles made for other markets are not necessarily designed to comply with the stricter (and thus costly) EU standards in mind.
This also applies to the physical and mechanical aspects of baby feeding bottles, as compliance requires that the EU requirements are taken into consideration on the drawing board. Once more, products intended for sales outside the EU are not necessarily designed with EU standards in mind.
ODM Products
Importers must verify compliance by requesting lab test reports or submitting the product for third-party testing before placing the order.
OEM Products
You must ensure that your product designer understands the mechanical safety aspects outlined in the relevant EN standards. Further, third-party lab testing is necessary to verify that the materials are compliant.
