. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/NLD/84 
11 December 2009  
 (09-6420) 
Committee on Technical Barriers to Trade Original:   English 
  
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Member to Agreement notifying:  NETHERLANDS
  
If applicable, name of local government involved (Article 3.2 and 7.2):     
2. Agency responsible:  Ministry of Health, Welfare and Sports 
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :  National Enquiry 
Point – EC WTO TBT Enquiry Point 
3. Notified under Article 2.9.2 [ X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:   
4. Products covered (HS or CCCN where applicab le, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):  Balloons 
5. Title, number of pages and language(s) of the notified document:  Decree of the 
Ministry of Health, Welfare and Sport, cont aining the laying down of a policy regulation 
concerning standards to be enforced with rega rd to the safety of balloons (4 pages, in 
English available).     
6. Description of content:  The policy regulation for balloons was laid down in the 
Netherlands in 2006. In this policy regulati on, technical requirements for balloons were 
stipulated, namely standards for the conten t of carcinogenic substances (nitrosamines and 
nitrosatable compounds) in the balloons a nd a mandatory warning  clause for on the 
packaging of balloons. This policy regulation was notified at that time (notification G/TBT/N/NLD/67). The new Dir ective from the European Parliament and the Council on 
the safety of toys, in Annex 2 (Particular Safety Requirements), Part III (Chemical 
Properties), point 8, prohibits the use of nitr osamines and nitrosatable substances in toys 
intended for children under 36 months and in othe r toys intended to be put into the mouth, 
if the migration of the substances is greater than or equal to 0.05 mg/kg for nitrosamines 
and  1 mg/kg for nitrosatable substances. The European Parliament and Council thus 
stipulate requirements for nitrosamines and nitrosatable compounds. For nitrosamines, the 
requirement is less strict than that stipulat ed in the policy regulation from 2006. In the 2006 
policy regulation, this requirement for nitrosamines is 0.01 mg/kg of rubber. The European requirement for nitrosatable compounds is equa l to that in the 2006 policy regulation. The 
Directive contains no stipulation directed at the obligation to show a warning clause on the 
label. This warning clause is still cons idered necessary, b ecause nitrosamines and 
nitrosatable compounds in balloons can also be formed after production, for example in 
stores or in the consumer’s cupboard. The 2006 policy regulation for balloons will be laid 
down again so that the requirement for nitros amines will become equal to the requirement 
in Directive 2009/48/EC (relaxation of the standard). For the rest, the 2006 policy regulation will be adopted.  G/TBT/N/NLD/84 
Page 2  
 
  7. Objective and rationale, including the natu re of urgent problems where applicable:  
The interest to be protected: public health. Fr om research by the Dutch Food and Consumer 
Product Safety Authority (in Dutch, VWA), it has been shown that balloons contain an increased concentration of carcinogenic nitr osamines and nitrosatable compounds. These 
substances, which are carcinogenic to humans, are released in sucking on balloons and are 
taken up in children, among others, via the m outh, not only during the inflation of balloons, 
but also by sucking (foreseen misuse). This is an undesirable situation, which is not 
compatible with a high protection level for young children.  
8. Relevant documents:   -   
9. Proposed date of adoption:   
Proposed date of entry into force:   }  March 2010 
  March 2010 
10. Final date for comments:  17 February 2010 
11. Text available from: National enquiry point [ X], or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:  
http://ec.europa.eu/enterprise/tbt