- Directive 2009/48/EC — Toy Safety for balloons
- Regulation (EU) 2023/988 — GPSR
- Regulation (EC) No 1907/2006 — REACH
- Regulation (EU) 2016/425 for some novelty items
Who has to appoint one
Sellers outside the Union placing party goods on the EU market. Latex balloons are toys under the Toy Safety Directive and carry a mandatory choking warning; foil balloons and decorations are generally consumer products.
Thresholds and exemptions
None. The choking warning for latex balloons applies regardless of packaging or price.
What must appear on the label
For balloons: CE marking, manufacturer and EU operator details, and the warning that children under eight must be supervised and that broken balloons must be discarded, in the prescribed wording. Nitrosamine limits apply to latex.
Marketplace fields
Marketplaces remove balloon listings without the choking warning. Helium canisters sold with balloons are pressure equipment and dangerous goods with their own restrictions.
Documentation you must hold
Safety assessment, technical documentation, EN 71 test reports including nitrosamine testing for latex, and REACH evidence for foil and decoration materials.
Standards and testing
EN 71-1 for mechanical hazards, EN 71-3 for migration, and EN 71-12 for N-nitrosamines and nitrosatable substances in latex balloons, which is a specific and frequently failed requirement.
Language requirements
Warnings in the language of each member state of sale.
When it applies
Before the product is made available.
How long records are kept
Ten years.
What happens if you do not comply
Withdrawal and Safety Gate alerts. Balloons are the leading cause of choking deaths among toy-related incidents, which is why the warning is mandatory and strictly enforced.
Who enforces it
Market surveillance authorities and customs.
Where the boundary lies
Helium canisters are transportable pressure equipment and dangerous goods, a completely different regime from the balloons they inflate. Sky lanterns are prohibited in several member states on fire safety grounds.
Questions we are asked
- Why do balloons need CE marking?
- Latex balloons are toys under Directive 2009/48/EC, with EN 71 testing including nitrosamines and the mandatory supervision warning.
- Are helium canisters included?
- They are separate products: transportable pressure equipment and dangerous goods for transport, with their own conformity and shipping rules.
Who signs for you
EU representative Europe Services, SE — Na Čečeličce 425/4, Smíchov, 150 00 Praha 5, Czech Republic
UK representative REP27 LTD — Unit 82a James Carter Road, Mildenhall, Suffolk IP28 7DE, United Kingdom