Europe to Improve Rules on Biocides

• Author: Gabrielle Williamson
• Position: Managing Partner of the Brussels office of Heuking Kühn Lüer Wojtek, a German law firm. She also practices in the firm's Düsseldorf office
• Pages: 20-20

Page 20 ❧ THE ENVIRONMENTAL FORUM Copyright © 2010, Environmental Law Institute®, Washington, D.C. www.eli.org.

Reprinted by permission from The Environmental Forum®, July/August 2010

Improing

harmonization

while reducing

administrative bu rdens

Europe to Improve

Rules on Biocides

Last year, the European Commis-

sion adopted a draft Regulation

on marketing and use of biocides. Bio-

cides destroy, deter, render harmless,

prevent the action of, or otherwise

control harmful organisms. ey are

used to purify drinking water, repel

insects, and clean hospitals. e Com-

mission promises that the new Regu-

lation will achieve a higher level of

protection by increasing safety, at little

cost. e Council has discussed the

proposal favorably, and the European

Economic and Social Committee en-

dorsed it. e Regulation is intended

to enter into force in 2013.

e new Biocides Regulation will

repeal the 1998 BiocidesDirective,

which introduced a two-tier autho-

rization process. Under this process,

which is maintained with modif‌ica-

tions in the draft Regulation, active

substances f‌irst have to be included

in an Annex. An active substance is a

substance or microorganism, includ-

ing a virus or a fungus, having general

or specif‌ic action against harmful or-

ganisms. A company wanting to place

a substance on the market has to apply

for its inclusion in the Annex. e ap-

plication must be addressed to the na-

tional authority, which will prepare an

evaluation. e dossier is forwarded

to the European Commission, which

decides on whether to include the sub-

stance in the Annex.

In a second step, a biocide must

be authorized before it may be placed

on the market, unless an exemption

for low-risk products or commodity

substances applies. Authorizations are

granted by the Member States for a

maximum of 10 years, provided that

the substance contained in the prod-

uct is listed in the Annex to the Direc-

tive and that other criteria are fulf‌illed.

e product has to be suf‌f‌iciently ef-

fective, have no unacceptable ef‌fect

on the target organisms, and must not

have unacceptable ef‌fects as a result of

its residues on human or animal health

or on the environment. If one Mem-

ber State has authorized a biocide, the

applicant can apply for mutual rec-

ognition in any other Member State,

which is swifter and easier than the

initial authorization.

e two-tier authorization process

is maintained under the new draft but

the procedures have been improved.

Applications for inclusion of an active

substance in Annex I of the Regula-

tion will be submitted to the Euro-

pean Chemicals Agency in Helsinki.

e applicant can choose which na-

tional authority shall

be responsible for

the evaluation of the

application after its

validation by ECHA.

Following the evalua-

tion, ECHA submits

an opinion on the in-

clusion of the substance to the Com-

mission. e Commission decides on

the inclusion in the Annex.

Under the new Regulation, a com-

pany that wishes to place a biocide

on the market can choose between a

national authorization or a Commu-

nity authorization. A national autho-

rization is awarded by the competent

authority of a Member State and al-

lows the holder to put the product on

it national market, provided that the

conditions for granting an authoriza-

tion are fulf‌illed. e mutual recogni-

tion procedures are amended, but the

concept remains the same.

Community authorization is valid

throughout the EU and confers the

same rights and responsibilities in each

Member State as a national authoriza-

tion. It is a convenient tool for compa-

nies that want to market their products

in several Member States. However,

Community authorization may only

be granted for biocides containing one

or more new active substances or for

low risk products.

Applications for Community au-

thorization are submitted to ECHA

along with the information of which

authority shall be responsible for the

evaluation. e national authority

prepares a document, which it sends

to ECHA, which, in turn, sends its

opinion to the Commission. Finally,

the Commission decides on authori-

zation of the product.

e draft Regulation also phases

out the most hazardous substances,

in particular those that may cause

cancer or fertility problems. ey will

only be authorized under strict condi-

tions; problematic substances will be

replaced by safer alternatives, where

possible. e Regulation introduces

rules for articles such as furniture and

textiles treated with biocides. It covers

devices that produce

biocides and biocides

that might come into

contact with food.

Similar to under

REACH, animal tests

may only be conduct-

ed once, and compa-

nies requesting authorization will be

required to share their data.

If the draft Regulation will enter

into force without undergoing major

changes in the remainder of the legis-

lative process, we can expect a regime

that provides for a higher degree of

harmonization, while of‌fering new

instruments that should reduce the

administrative burden of business and

improve protection against the most

dangerous substances.

By Gabrielle Williamson

A V   EU

gabrielle H. William son is Managi ng

Partn er of the Brussels ofce of H euking

Kühn Lüe r Wojtek, a German law rm. She

also practices i n the rm’s Düsseldor f of-

ce. S he can b e reached at g.williamson@

heuking.de.