瑞士全国贸易委员会对“REACH”的评议意见

Internal Market Division 2003-07-09 Dnr 154-1610-2003

REACH Regulation – Public Internet Consultation

– comments by the Swedish National

Board of Trade

The National Board of Trade welcomes the new regulation to regulate

chemicals to ensure a high level of protection for human health and the

environment, while ensuring the efficient functioning of the internal

market. The public internet consultation is a useful means to guarantee a

more transparent preparation of Community legislation and contributes to

a more active participation of the parties concerned.

However, the implementation of REACH should also contribute to

achieving the maintenance and enhancement of the competitiveness of

the EU chemical industry and ultimately the goals set in Lisbon 2000.

The Board conducted a study that was presented to the Swedish Foreign

Ministry in November 2002. Having consulted Swedish industry and

authorities, the Board demonstrated in its study that the “Strategy for a

Future Chemicals Policy” caused high uncertainty among involved parties

regarding the economic effects on industry, especially SME:s and

parallel traders. Most of the problems seem to remain in the proposed

regulation. The Board therefore submits its study to the European Commission.

Annex IV to the study contains a summary of industry viewpoints

and should be of interest to the Commission.

Concerning the draft regulation, the Board notes that the legal text is

rather complex and difficult to read. As the regulation has to be applied

by all the parties concerned it would be useful to rewrite the regulation in

a more understandable way to make it possible, for example for producers

and importers, to achieve relevant information. Otherwise, the competitiveness

of small and medium-sized companies in the internal market

could be jeopardized.

Industry has to demonstrate that they are managing their chemical substances

in a safe way and that provisions in REACH are complied with.

The Board considers that further analysis is needed to study the practical

effects of this legal text and to ensure certainty and clarity for all parties

involved. For example, the requirement in point 63 “producers and importers

of articles shall ensure that the articles they place on the market

can be used in such a way that human health and the environment are

not adversely affected as a result of exposure to any substances released

from them” leaves doubts as to how it is to be measured and controlled.

The Board assumes, that the conformity of the new regulation with current

WTO-rules – in particular title X concerning substances in articles -

has been looked at and will be further analysed by the Commission in

order to achieve full conformity.

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2003-07-09

As a further problem, mention should be made of the relation between

SME:s and larger companies as well as the special situation of parallel

traders. The possibilities to refer to already registered chemicals and to

open up access to information for parallel traders should, according to

our opinion, be taken into consideration. The measures required must

also be cost effective and the burden on industry reasonable.

The Board would, moreover, like to submit to the Commission proposals

included in the study, on how to improve the interaction between on the

one hand harmonized secondary law dealing with product safety (mainly

New Approach directives) and on the other, those Community legal acts

dealing with chemicals. The Board endorses the creation of a system

where the current core structure of the New Approach basically is preserved,

but where the basic instruments are adjusted in order to better

deal with long-term health and environmental concerns.

In short, the Board recommends that:

_ It should be the task of the legislator to formulate concrete safety

requirements in new approach directives.

_ The safety requirements should, apart from being formulated in

general terms in the essential requirements articles, also be specified

in annexes that form part of the directives. The annexes

should contain technical specifications in order to regulate specific

chemical/environmental risks attributable to products covered

by the directive.

_ These annexes should be subject to upgrading in order to take into

consideration new risks that are detected as a result of the

REACH system. The fact that these technical specifications are

contained in annexes to the directives makes it possible to upgrade

these annexes by means of a regulatory committee. This

way new scientific findings may be integrated into the harmonized

product legislation.

_ General, non-product specific risks, should continue to be regulated

by the harmonised horizontal chemical legal acts. Means to

secure the interaction between horizontal and product specific legal

acts should be introduced.

_ Standards should, when it comes to chemical/environmental risks,

contain methods and instruments for conformity assessment.

These instruments should be connected with the present day “presumption

of conformity” and facilitate the procedure resulting in

the CE-marking of the product.

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2003-07-09

H?kan Jonsson

Acting Director General

National Board of Trade