Baby feeding bottles are for obvious reasons strictly regulated in the European Union. In this guide, we cover relevant chemical regulations, safety standards, labeling requirements, documentation, lab testing, and more. We also cover safety risks that baby feeding bottle importers and manufacturers must be aware of.
EN 14350 – Child Care Articles. Drinking Equipment
EN 14350 specifies safety requirements for certain types of drinking equipment intended for children of 0-48 months of age. This standard lays down requirements relating to the materials, construction, performance, packaging, and labeling requirements for drinking equipment.
More specifically, the standard provides mechanical and chemical property testing standards and procedures for all the components comprising drinking equipment.
EN 14350 covers the following products:
- Reusable and single-use baby bottles and containers
- Reusable and single-use drinking accessories (sold with the containers)
- Feeding teats
The accessories of drinking equipment include all small parts of the drinking equipment, such as mouthpiece, feeding spout, straw, protective cover, feeding teat, locking ring, drinking cup, and handle.
The standard does not cover the following baby’s drinking equipment for consumer use:
- Drinking equipment made from ceramics
- Other feeding utensils
General Product Safety Directive
EN 14350 is harmonized under the General Product Safety Directive (GPSD), which requires all consumer products, including baby bottles, to be safe for the user.
Besides compliance with the safety requirements, which can be achieved by complying with EN 14350, the General Product Safety Directive also requires to prepare some documentation such as:
- Risk Assessment Report
- User Manual
- Technical File
- Test Reports
Substances Migration Limits
EN 14350 sets the maximum allowable migration limits for heavy metals and other substances contained in the drinking equipment. Below we list some of these migration limits.
|Substance Name||Migration Limit (mg/kg)|
|Primary Aromatic Amines||0.01|
Note that EN 14350 doesn’t limit phthalates and Bisphenol A, as these substances are deemed to be already sufficiently limited by other regulations, such as REACH and Regulation (EU) 10/2011 for plastic food contact products.
EN 14350 doesn’t provide unified testing standards. All parts of the drinking equipment, such as the main body of the bottle, sealing discs, finger traps, handles and clips, feeding spouts, straws, or any other drinking accessories must be tested under specific requirements and procedures. As an example, it refers to EN 71-3 to determine the migration of certain elements.
We recommend that you let a third-party testing company decide which testing standards to follow.
The standard specifies the usage, hygienic care instructions, and warning statements that should be placed on the label on the drinking equipment or its product packaging.
Traceability information such as the name, trademark, address, website address of the manufacturer, distributor, or retailer should also be displayed on the product label.
The standard specifies the form, content, and placement of warning statements that should be used for drinking equipment. It requires that warning statements should be legible and placed in a conspicuous position of the equipment, without mixing other commercial information in it.
The following heading shall be used for the warning section:
For your child’s safety and health
The following are examples of some warning statements that should be provided on the label:
a. Always use this product with adult supervision
b. Throw away at the first signs of damage or weakness
Additional warning statements should be added according to the property of the feeding equipment. For example, for bottles containing cords or strings, a statement warning about the danger of strangling should be added.
Regulation (EU) 2018/213: Infant and Children Cups and Bottles
Regulation (EU) 2018/213 is an amendment document of Regulation (EU) No 10/2011: Plastic Food Contact Materials, which bans the use of Bisphenol A in materials used to manufacture:
a. Polycarbonate infant feeding bottles
b. Polycarbonate spill-proof drinking cups or bottles that are intended for infants and young children
Directive 93/11/EEC: Teats and Soothers
Directive 93/11/EEC sets specific requirements concerning the release of N-nitrosamines and N-nitrosatable substances on teats and soothers that are made or contain elastomer or rubber.
Specifically, the directive appoints testing methods and the following migration limits:
a. N-nitrosamines < 0.01 mg/kg of the parts teats or soothers made of elastomer or rubber
b. N-nitrosatable < 0.1 mg/kg of the parts made of elastomer or rubber
EU Food Contact Materials Framework Regulation
The Food Contact Materials Framework Regulation is an umbrella regulation that sets out the regulatory framework regulating the safe use of food contact materials placed on the EU market.
This section covers several derivative regulations that are relevant for feeding bottles
Regulation (EU) 10/2011: Plastic Food Contact Materials
Regulation (EU) 10/2011 regulates plastic materials and articles intended to come into contact with food, mainly from the perspective of specific migration value of certain chemical substances, which could be carcinogenic or toxic to humans.
The regulation provides a list of substances that can be used for the manufacturing of plastic food contact products, materials, or components, provided that the specified migration limits are respected.
For each listed substance, a specific migration limit might be set. Below we provide some examples:
- Copper < 5 mg/kg of plastic
- Lead < 2 mg/kg of plastic
- Arsenic < 1 mg/kg of plastic
- Chromium < 1 mg/kg of plastic
- Nitrogen < 2,500 mg/kg of plastic
Also, Article 12 of the regulation requires that general food contact products made of plastic materials should not transfer more than 10 milligrams of all chemical substances combined into any square decimeter of food contact surface (mg/dm2).
Particularly, for plastic food contact products intended to come into contact with infants and young children, constituents migrated to foodstuff should be less than 60 mg/kg of total constituents.
As already mentioned, an amendment of this regulation prohibits the use of Bisphenol A in infant feeding bottles made of polycarbonate, which is a type of plastic.
Regulation (EC) 1895/2005: Epoxy Derivatives Restriction
This regulation sets migration limits or bans for the following epoxy derivatives that might be used in plastic materials and articles intended to come into contact with food:
- BADGE and some of its derivatives
Regulation (EU) 284/2011: Food Contact Materials from China or Hong Kong
Regulation (EU) No 284/2011 requires that polyamide and melamine plastic kitchenware originated from Mainland China or Hong Kong must go through certain examination procedures to limit the content of formaldehyde and primary aromatic amines.
Currently, the regulation sets the following migration limits:
- Primary aromatic amines < 0.01 mg/kg
- Formaldehyde < 15 mg/kg
Declaration of Compliance (DoC)
Importers of plastic food contact products to any member state of the EU must submit a Declaration of Compliance, for each consignment, confirming that the products are safe and compliant with the requirements.
The Declaration of Compliance should include the following information:
- Company name
- Valid postal address
- Batch ID
- Type of food/beverages for which the product shall be used
- Treatment (ie. temperature, etc)
- Applicable standards/regulations
- Test reports
Good Manufacturing Practice (GMP)
In order to comply with applicable regulations and coercive safety standards, manufacturers and importers must implement good manufacturing practices during every stage of the production process.
The proper implementation of the GMP involves documentation, personnel training, quality checks before, during, and after the production processes, and more.
In order to facilitate market supervision and risk management, traceability information should be shown on the product label or accompanying documentation such as:
- Batch number
- Company name
- Company address
- Contact details
REACH is an EU regulation that lays down the rules and sets up limits for certain toxic chemical substances used in general consumer products.
In 2017, BPA was added to the Candidate List of Substances of Very High Concern (SVHC) of REACH as a category 1B hazardous substance. The concentration level of BPA should be less than 0.1% by weight in baby bottles.
Other than BPA, importers should also ensure that the baby bottles they import to the EU do not contain an excessive amount of REACH-restricted heavy metals and other toxic chemicals, such as lead, phthalates, and polycyclic aromatic hydrocarbons.
National Baby Bottles Regulations
Several European countries have developed their own regulations restricting the use of Bisphenol A in feeding bottles. Below, we list some of these regulations.
Law No. 2012-1442 of 24 December 2012 in France prohibits the use of Bisphenol A on baby bottles. The restriction also applies to food contact packaging and containers.
Denish Statutory Order No. 822 prohibits the use of Bisphenol A in food contact materials designed to be used by children under the age of 3 years old, which includes infant feeding bottles.
Belgium Act of 4 Sept 2012 forbids the use of Bisphenol A in food containers, including nursing bottles, intended to be used by children under the age of 3 years old.
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.
Importers must verify compliance by requesting lab test reports or submitting the product for third-party testing before placing the order.
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.
As mentioned, third-party lab testing is required to verify both mechanical safety and material substance compliance. Given the relative complexity of baby feeding bottles, testing costs often range in the thousands of dollars.
Here’s a list of third-party testing companies covering baby feeding bottles: