COMMISSION DECISION  
of 28 May 2009  
amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of 
organostannic compounds for the purpose of adapting its Annex I to technical progress  
(notified under document number C(2009) 4084)  
(Text with EEA relevance)  
(2009/425/EC)  
THE COMMISSION OF THE EUROPEAN COMMUNITIES,  
Having regard to the Treaty establishing the European 
Community,  
Having regard to Council Directive 76/769/EEC of 27 July 
1976 on the approximation of the laws, regulations and admin ­
istrative provisions of the Member States relating to the 
restrictions on the marketing and use of dangerous substances 
and preparations (  1 ), and in particular Article 2a thereof,  
Whereas:  
(1) Tri-substituted organostannic compounds were 
previously widely used in antifouling paints on ships. 
However, such paints were found to pose risks for 
aquatic organisms through endocrine disruptive effects. 
The use of organostannic compounds, also known as 
organotin compounds, in antifouling paints was 
therefore restricted in Directive 76/769/EEC, and in 
Regulation (EC) No 782/2003 of the European 
Parliament and of the Council of 14 April 2003 on 
the prohibition of organotin compounds on ships (  2 ). 
Furthermore, tri-substituted organostannic compounds 
may no longer be used as biocides under Directive 
98/8/EC of the European Parliament and of the Council 
of 16 February 1998 concerning the placing of biocidal 
products on the market (  3 ). However articles treated with 
such biocides may still be imported into the Community.  
(2) Di-substituted organostannic compounds, including in 
particular dibutyltin compounds (DBT) and dioctyltin 
compounds (DOT), are widely used in consumer 
articles where they function either as a stabilizer or as 
a catalyst.  
(3) The use of organostannic compounds in consumer 
articles has been found to pose a risk to human health, 
particularly for children. The specific risks to the health 
of children and adults from various consumer articles 
have been identified in a risk assessment (  4 ), and have 
been confirmed by the Commission’s Scientific Committee on Health and Environmental Risks (SCHER) 
in its opinion of 30 November 2006 (  5 ). 
(4) Although di-substituted and tri-substituted organostannic 
compounds have the same adverse health effect, namely 
immunotoxicity via the thymus gland, and act in a 
cumulative way, the potency of the tri-substituted 
compounds (such as TBT and TPT) is greater than that 
of the di-substituted compounds (DOT and DBT). 
Furthermore, tri-substituted organostannic compounds 
being emitted from articles for either consumer or 
professional use could have adverse effects on the 
environment — in particular on aquatic organisms. 
More severe restrictions should therefore be imposed 
on articles containing tri-substituted organostannic 
compounds.  
(5) Certain DBT compounds (dibutyltin dichloride, CAS: 
683-18-1, and dibutyltin hydrogen borate, CAS: 
75113-37-0) will soon be classified in the framework 
of Council Directive 67/548/EEC (  6 ) as toxic to repro ­
duction, category 2, and it will subsequently be 
prohibited to sell the substances and mixtures containing 
them to consumers (  7 ). More severe restrictions should 
therefore be imposed on articles containing DBT 
compounds, allowing for continued use for an additional 
period of time only where no suitable alternatives are 
available such as catalysts in RTV-1 and RTV-2 
sealants, paints and coatings, or PVC stabilisers in 
certain products (for example coated fabrics, PVC 
profiles) to allow the development of suitable alter ­
natives, or where the articles concerned are already 
regulated by other more specific legislation.  
(6) Exposure to DOT compounds is highest from certain 
specific consumer articles such as printed textiles, 
gloves, footwear, wall and floor coverings, female 
hygiene products, nappies, and two-component silicone 
moulds.  
(7) Despite the availability of alternatives for most uses to be 
restricted, certain producers of articles containing DOT 
and DBT will need time to adapt, and an appropriate 
transition period should be therefore foreseen for these 
applications.EN 4.6.2009 Official Journal of the European Union L 138/11  
( 1 ) OJ L 262, 27.9.1976, p. 201.  
( 2 ) OJ L 115, 9.5.2003, p. 1.  
( 3 ) OJ L 123, 24.4.1998, p. 1.  
( 4 ) Risk assessment studies on targeted consumer applications of certain 
organotin compounds. RPA study finalised in September 2005. 
http://ec.europa.eu/enterprise/chemicals/studies_en.htm  ( 5 ) http://ec.europa.eu/health/ph_risk/committees/04_scher/ 
scher_opinions_en.htm  
( 6 ) OJ 196, 16.8.1967, p. 1.  
( 7 ) In accordance with entries 29, 30 and 31 of Directive 76/769/EEC.(8) Directive 76/769/EEC should therefore be amended 
accordingly.  
(9) This Decision is without prejudice to the Community 
legislation laying down minimum requirements for the 
protection of workers, such as Council Directive 
89/391/EEC of 12 June 1989 on the introduction of 
measures to encourage improvements in the safety and 
health of workers at work (  1 ) and individual Directives 
based thereon, in particular Directive 2004/37/EC of 
the European Parliament and of the Council of 
29 April 2004 on the protection of workers from the 
risks related to exposure to carcinogens or mutagens at 
work (Sixth individual Directive within the meaning of 
Article 16(1) of Council Directive 89/391/EEC) (codified 
version) (  2 ) and Council Directive 98/24/EC of 7 April 
1998 on the protection of the health and safety of 
workers from the risks related to chemical agents at 
work (fourteenth individual Directive within the 
meaning of Article 16(1) of Directive 89/391/EEC) (  3 ). 
(10) The measures provided for in this Decision are in 
accordance with the opinion of the Committee on the adaptation to technical progress of the Directives for the 
elimination of technical barriers to trade in dangerous 
substances and preparations,  
HAS ADOPTED THIS DECISION:  
Article 1  
Annex I to Directive 76/769/EEC is amended in accordance 
with the Annex to this Decision.  
Article 2  
This Decision is addressed to the Member States.  
Done at Brussels, 28 May 2009.  
For the Commission  
Günter VERHEUGEN  
Vice-PresidentEN L 138/12 Official Journal of the European Union 4.6.2009  
( 1 ) OJ L 183, 29.6.1989, p. 1.  
( 2 ) OJ L 158, 30.4.2004, p. 50; corrected by OJ L 229, 29.6.2004, 
p. 23.  
( 3 ) OJ L 131, 5.5.1998, p. 11.ANNEX  
The following paragraphs are added to Entry 21, ‘Organostannic compounds’, of Annex I to Directive 76/769/EEC:  
‘4. Tri-substituted organostannic compounds 
(a) Tri-substituted organostannic compounds such as tributyltin (TBT) compounds and triphe ­
nyltin (TPT) compounds shall not be used after 1 July 2010 in articles where the concen ­
tration in the article, or part thereof, is greater than the equivalent of 0,1 % by weight of tin. 
(b) Articles not complying with paragraph 4(a) shall not be placed on the market after 1 July 
2010, except for articles that were already in use in the Community before that date. 
5. Dibutyltin (DBT) compounds 
(a) Dibutyltin (DBT) compounds shall not be used after 1 January 2012 in mixtures and articles 
for supply to the general public where the concentration in the mixture or the article, or part 
thereof, is greater than the equivalent of 0,1 % by weight of tin. 
(b) Articles and mixtures not complying with paragraph 5(a) shall not be placed on the market 
after 1 January 2012, except for articles that were already in use in the Community before that 
date. 
(c) By way of derogation, paragraphs 5(a) and (b) shall not apply until 1 January 2015 to the 
following articles and mixtures for supply to the general public: 
— one-component and two-component room temperature vulcanisation sealants (RTV-1 and 
RTV-2 sealants) and adhesives, 
— paints and coatings containing DBT compounds as catalysts when applied on articles, 
— soft polyvinyl chloride (PVC) profiles whether by themselves or coextruded with hard PVC, 
— fabrics coated with PVC containing DBT compounds as stabilisers when intended for 
outdoor applications, 
— outdoor rainwater pipes, gutters and fittings, as well as covering material for roofing and 
façades. 
(d) By way of derogation, paragraphs 5(a) and (b) shall not apply to materials and articles 
regulated under Regulation (EC) No 1935/2004 of the European Parliament and of the 
Council of 27 October 2004 on materials and articles intended to come into contact with 
food (*). 
6. Dioctyltin (DOT) compounds 
(a) Dioctyltin (DOT) compounds shall not be used after 1 January 2012 in the following articles 
for supply to, or use by, the general public, where the concentration in the article, or part 
thereof, is greater than the equivalent of 0,1 % by weight of tin: 
— textile articles intended to come into contact with the skin, 
— gloves, 
— footwear or part of footwear intended to come into contact with the skin, 
— wall and floor coverings, 
— childcare articles, 
— female hygiene products, 
— nappies, 
— two-component room temperature vulcanisation moulding kits (RTV-2 moulding kits), 
(b) Articles not complying with paragraph 6(a) shall not be placed on the market after 1 January 
2012, except for articles that were already in use in the Community before that date.  
(*) OJ L 338, 13.11.2004, p. 4.’EN 4.6.2009 Official Journal of the European Union L 138/13