EN    EN  COMMISSION OF THE EUROPEAN COMMUNITIES  
Brussels, 4.11.2008  
XXX  
  
Draft  
COMMISSION DECISION  
of […]  
amending  Council Directive 76/769/EEC as regards restrictions on the marketing and 
use of organ ostannic compounds  for the purpose of adap ting its Annex I to technical 
progress   
EN 2   EN Draft  
COMMISSION DECISION  
of  
amending  Council Directive 76/769/EEC as regards restrictions on the marketing and 
use of organostannic compounds  for the purpose of adap ting its Annex I to technical 
progress  
(Text with EEA relevance)  
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 administrative provisions of the Members States relating to the 
restrictions on the marketing and use of dangerous substances and preparations1, and in 
particular Article 2a thereof,  
Whereas:  
(1) Tri-substituted organostannic compounds w ere 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 paint s was therefore restricted in 
Directive 76/769/EEC, and in Regulation (EC) No 782/2003 of the European 
Parliament and the Council on the prohibition of organotin compounds on ships2. 
Furthermore, tri -substituted organostannic compounds may no longer be use d 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 market3. 
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 co nsumer 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 
assessment4, and have been confirmed by the Comm ission’s Scientific Committee on 
Health and Environmental Risks (SCHER) in its opinion of 30 November 20065. 
                                                
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 stud ies 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    
EN 3   EN (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 eithe r 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 (d ibutyltin chloride, CAS: 683 -18-1, and dibutyltin hydrogen 
borate, CAS: 75113 -37-0) will soon be classified in the framework of Directive 
67/548/EEC as toxic to reproduction, category 2, and it will subsequently be 
prohibited to sell the substances and mixtures  containing them to consumers6. 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 alternatives, or where the articles 
concerned are already regulated by other more speci fic 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 availabili ty 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.  
(8) Directive 76/769/EEC should therefor e 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 
impr ovements in the safety and health of workers at work7 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)8 and 
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety 
of workers fr om the risks related to chemical agents at work (fourteenth individual 
Directive within the meaning of Article 16(1) of Directive 89/391/EEC)9. 
(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 . 
                                                
6 In accordance with points 28 -30 of Directive 76/769/EEC.  
7 OJ L 183, 29.6.1989, p.1.  
8 OJ L 158, 3 0.4.2004, p.50.  
9 OJ L 131, 5.5.1998, p.11.   
EN 4   EN HAS ADOPTED THIS DECISION:  
Article 1  
Annex I to Directive 76/769/EEC is amended in accordance w ith the Annex to this Decis ion. 
Article 2 
This Decision is addressed to the Member States.  
Done at Brussels,  
 For the Commission  
  
 Member of the Commission   
EN 5   EN ANNEX  
The following paragraphs are added in column "Conditions of Restrictions" in Entry 20 . 
"Organostannic compounds" of Ann ex I to Directive 76/769/EEC:  
“ 
 4. Tri-substituted organostannic compounds  
(a) Tri-substituted organostannic compounds such as 
tributyltin (TBT) compounds and triphenyltin (TPT) 
compounds shall not be used  after  1 July 2010  in articles 
where the concentra tion 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 th at date.  
5. Dibutyltin (DBT) compounds  
(a) Dibutyltin (DBT) compounds shall not be used  after 
1 January  2012  in mixtures  and a rticles for supply to the 
general public where the conce ntration in the mixture  or 
the article, or a part thereof, is gr eater than 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 th at date.  
(c) By way of derogation , paragraph s 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 temper ature 
vulcanisation sealants (RTV -1 and RTV -2 sealants) and 
adhesives , 
– paints and coatings containing DBT compounds as 
catalysts when applied o n 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 
cover ing material  for roofing and façades.  
(d) By way of derogation, paragraphs 5 (a) and (b)  shall not 
apply to m aterials and articles regulated under Regulation 
(EC) No 1935/2004 of the European Parliament and of the  
EN 6   EN Council of 27 October 2004 on materials and articles 
intended to come into contact with food10. 
6. Dioctyltin (DOT) compounds  
(a) Dioctyltin (DOT) compounds shall not be used after 
1 January  2012  in the follow ing articles for supply to , or 
use by, the general public,  where the concentration in the 
article or part thereof is greater than 0.1  % by weight  of 
tin: 
– textile articles intended to come in contact with the 
skin, 
– gloves,  
– footwear or part of footwear  intended to come in to 
contact with the skin , 
– wall and floor coverings , 
– childcare articles , 
– female hygiene products,  
– nappies , 
– two-component room te mperature vulcanisation 
moul ding kits (RTV -2 moulding kits).  
(b) Articles not complying with paragr aph 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.  
” 
                                                
10 OJ L 338, 13.11.2004, p.1.