Archive: Approval of antifouling biocides and products
Actually, some confusion exists with respect to substances which can be used as biocides in antifouling products in the future and which antifouling products can be placed on the market containing notified existing substances. It has to be discriminated between notified existing substances without any submission for approval and those for which dossiers have been submitted to the competent authorities in several european countries. As no single substance has been included in the Annex (date 1st of March 2012) for the product type 21 (antifouling prducts), there is some uncertainty about the legal situation. We tried to clarify the background to a certain degree.
Existing active substances
The notification procedure for substances notified under the Chemicals Act (ChemG) and the notification procedure for existing substances under Regulation (EEC) No 793/93 were repealed on 1 June 2008 by Regulation (EC) No 1907/2006 (REACH). Since then all substances manufactured in quantities of one tonne or more per year in the EU or substances imported into the EU in these amounts have to be registered at the European Chemicals Agency (ECHA) in Helsinki. Existing active substances for which a decision of non-inclusion into Annex I or Ia of Directive 98/8/EC has been adopted. In accordance with Article 4(2) of Regulation (EC) No 2032/2003, biocidal products containing active substances for which a noninclusion decision was taken should be removed from the market within 12 months of the entering into force of such decision.
The following substances used in the product type Antifouling Products (PT 21) are not allowed to incorporate into formulations placed on the market since the end of 2008 at the latest:
Cetylpyridinium chloride, Captan, N-(trichloromethylthio)phthalimide / Folpet
Ziram, Thiabendazole, Diuron
Zinc sulphide, Chlorothalonil, Fluometuron
Prometryn, Sulphur dioxide, Iodine
Sodium hydrogensulphite, Disodium disulphite, Sodium sulphite
Lignin, Potassium sulphite, Dodecylguanidine monohydrochloride
Chlorotoluron, Dipotassium disulphite
3-(4-isopropylphenyl)-1,1-dimethylurea / Isoproturon
Cis-4-[3-(p-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine / Fenpropimorph
Quaternary ammonium compounds, benzyl-C12-18-alkyldimethyl, chlorides
Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides
Quaternary ammonium compounds, benzyl-C12-14-alkyldimethyl, chlorides
Quaternary ammonium compounds, C12-14-alkyl[(ethylphenyl)methyl]dimethyl, chlorides
Chloromethyl n-octyl disulfide
4-Bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1H-pyrrole-3-carbonitrile / Chlorfenapyr
Homopolymer of 2-tert-butylaminoethyl methacrylate Polymer
Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride) Polymer
Poly(hexamethylendiamine guanidinium chloride) Polymer
Existing substances which have been notified and a dossier has been submitted can be placed on the market until a decision on approval or rejection has been published. Approved existing substances will be included in the Annex and are going to be published in Germany on www.baua .de. As no decision has been published, they can be placed on the market in antifouling products until May 14, 2014 at the latest.
For the following existing substances dossiers have been submitted and they can be incorporated into antifouling products:
copper metal powder
For the following new substances dossiers have been submitted for the approval in produtct type 21.
Despite of the period until May 2014 in which antifouling products with notified biocides for which dossiers have been submitted can be placed on the market, the first entrance of substances in the annex can be expected in the course of 2012. For the product type 21 there may be approvals of biocides only to be used in seawater or for professional use only which is associated with specific considerations concerning their use in antifouling products. According to the revision of the BPD adopted in November 2011 approvals will be exclusively stated by ECHA valid for all European countries. Concerning the product type 21 a statement will be drafted until December 2017 for the general approval of antifouling products by ECHA.