2/2008 Biosinfo newsletter

March 2008
SEMINAR ON CURRENT BIOCIDAL ISSUES
SYKE and STTV will organize a seminar on biocides 8 – 9 April 2008. During the first day basics on the Biocides Directive will be discussed. The focus of the second day will be on the review programme and on authorization procedures for biocidal products. The seminar will take place in the Finnish Environment Institute in Helsinki. Language of the seminar is Finnish.

Registration 28 March 2008 at latest.

Registration form and programme (In Finnish)


MORE ACTIVE SUBSTANCES INTO ANNEX I
Four active substances were voted for Annex I inclusion in February. They are K-HDO, thiabendazole, thiamethoxam and IPBC as wood preservatives. Substance specific inclusion directives will be published within few months. Read more.

Published inclusion directives.
AUTHORISATION OF BIOCIDAL PRODUCTS
Wood preservatives with sulfuryl fluoride or dichlofluanide as a sole active substance are the first biocidal products for which authorisation has to be applied. Read more.

Time-line for applications is stipulated in the Ministry of the Environment Decree 20/2008. Applications have to be made within two years from the entry into force of the inclusion directives. Decisions on the applications shall be made within subsequent two years.  Read more (pdf).

SYKE and STTV will publish guides and forms for application on their websites at the end of 2008
CREOSOTE – RISK-BENEFIT ANALYSIS
In the Review Programme of existing active substances creosote oil as a wood preservative has been evaluated by Sweden. Based on the hazard assessment and risk characterisation for human health an inclusion in Annex I could not be recommended. It was also recommended that the benefits of creosote products should be analyzed before a final decision is taken.

For the risk-benefit analysis all stakeholders may provide data on risks, need and especially on substitutive materials, wood preservation methods and alternative wood preservatives. Consultation will be published on the Commission website in the near future.
REVISION OF THE BIOCIDES DIRECTIVE
Revision of the Biocides Directive has been started. The Commission will prepare a proposal for new regulation in the end of 2008. The focus of the revision is simplification of the regulation. In Finland competent authorities SYKE and STTV as well as the Ministry of the Environment are involved in the revision.

In May the Commission will organize an open stakeholder seminar on the revision of the Directive. Follow the progress of the revision process.


BIOCIDES AND REACH
The new Regulation on chemicals, REACH (1907/2006/EC), creates obligations to companies which produce or formulate biocidal products or import them outside the EU.

Pre-registration according to REACH shall be made between 1 June 2008 and 1 December 2008 to the European Chemicals Agency (ECHA). Biocidal active substances are regarded as registered within REACH. Thus, they do not require separate pre-registration or registration for biocidal uses. All the other components in the biocidal products shall be pre-registered and registered.

If you produce or formulate biocidal products, make sure that your suppliers have included the use of their chemicals in biocidal products in their registration. Without registration the use of the substances is not allowed unless producer/importer self makes a chemical safety report (CSR) and informs ECHA about it.

Your national REACH Help Desk will provide further guidance.


BIOSINFO NEWSLETTER
BIOSINFO is an electronic newsletter on current biocide issues. The newsletter is aimed at companies responsible for placing biocidal products on the Finnish market and other stakeholders in the biocides area. It will be published 3-5 times per year.

If you have received this newsletter directly from SYKE, you are already on our mailing list. To subscribe or to cancel subscription please use the link at the end of this newsletter.

BIOSINFO Archive

The Finnish Environment Institute (SYKE) and The National Product Control Agency for Welfare and Health (STTV) are the Finnish competent authorities for the Biocides Directive (BPD). They are responsible for the authorization of biocidal products in Finland as well as assessments of active substances. Information on the procedures related to the BPD is available on our websites in Finnish, Swedish and English.

FURTHER INFORMATION

Finnish Environment Institute (SYKE)

Eeva Nurmi

Tiina Tuusa

E-mail: syke_kem_biosinfo "at"  ymparisto.fi

National Product Control Agency for Welfare and Health (STTV)

Paula Haapasola

E-mail: biocides "at" sttv.fi


REACH www.reachneuvonta.fi