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12.6.

2003 EN Official Journal of the European Union C 137 E/227

Answer given by Mr Byrne on behalf of the Commission

(23 January 2003)

No pharmaceutical or other company was involved in the drafting of the Directive 2002/46/EC of the
Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Members States
relating to food supplements (1).

(1) OJ L 183, 12.7.2002.

(2003/C 137 E/257) WRITTEN QUESTION E-3565/02


by Markus Ferber (PPE-DE) to the Commission

(12 December 2002)

Subject: Agreement between the European Union and Israel

1. Was an agreement signed between the EU and Israel in April 2002 which provides for mutual
recognition of preclinical tests?

2. If so, exactly what provisions does it contain?

3. If so, what is the purpose of the agreement?

Answer given by Mr Liikanen on behalf of the Commission

(31 January 2003)

The Agreement between the Union and Israel, to which of the Honourable Member refers, concerns the
mutual recognition of the Organisation for Economic Cooperation and Development (OECD) principles of
Good Laboratory Practice (GLP) and of the respective GLP compliance monitoring programmes.

The principles of Good Laboratory Practice GLP) define a set of rules and criteria for a quality system
concerned with the organisational process and the conditions under which non-clinical health and
environmental safety studies are planned, performed, monitored, recorded, archived and reported.

The recognition of test data generated in accordance with the principles of GLP by the authorities in
several countries avoids duplicative testing, is beneficial to animal welfare and reduces costs for industry
and governments. Moreover, common principles for GLP facilitate the exchange of information and
prevent the emergence of non-tariff barriers to trade, while contributing to the protection of human health
and the environment.

The Mutual Recognition Agreement (MRA) between the Union and Israel was concluded by Council
Decision 1999/662/EC of 19 July 1999 concerning the conclusion of the Agreement on mutual
recognition of OECD principles of good laboratory practice (GLP) and compliance monitoring programmes
between the Community and the State of Israel (1) and has entered into force on 1 May 2000.

According to this agreement, the Parties shall recognise the equivalence of each other’s compliance
monitoring programmes on GLP based on the OECD principles of GLP and other relevant OECD
documents. The Parties shall therefore accept studies and data generated by GLP compliant test facilities
located on the territory of the other party and intended to be used to allow the placing on the market of
all chemicals defined in the agreement.
C 137 E/228 Official Journal of the European Union EN 12.6.2003

According to Article 11(1) of the agreement, Israel shall establish a national GLP monitoring system during
a transitional period of a maximum of two years, starting after the entry into force of this Agreement.
According to Articles 11(2) and 11(3), the Community shall acknowledge the establishment and
satisfactory entry into operation of the national GLP monitoring system in Israel before the transitional
period may be terminated.

Since Israel has fulfilled the requirement, the Commission has acknowledged this by Commission Decision
2002/227/EC of 13 March 2002 on the acknowledgement of the establishment and satisfactory entry into
operation of the Israeli good laboratory practice (GLP) monitoring system (2). On this basis, the MRA with
Israel on GLP entered into its operational phase on 1 May 2002.

(1) OJ L 263, 9.10.1999.


(2) OJ L 75, 16.3.2002.

(2003/C 137 E/258) WRITTEN QUESTION E-3570/02


by Jonas Sjöstedt (GUE/NGL) to the Commission

(12 December 2002)

Subject: Private imports of wine into Sweden

The Swedish Government maintains that all orders of wine to be imported into Sweden must go through
Systembolaget and must be subject to Swedish VAT, Swedish alcohol tax, transport and Systembolaget’s
mark-up.

Newspaper reports claim, however, that the Commission wrote to the Swedish Foreign Minister in early
November 2002 saying that the provisions of the Swedish Law on Alcohol which prohibit individuals
from acquiring alcohol abroad and having it transported to Sweden by an independent agent constitute an
obstacle to trade in the Community.

The position of the Swedish Government and Parliament is that all remote sales must go through
Systembolaget. The Court of Justice has also given much consideration, from the point of view of policy,
to Systembolaget’s retail trading monopoly in a judgement given in Case C-189/95.

What are the Commission’s intentions in terms of policy with the abovementioned letter to the Swedish
Government?

Answer given by Mr Bolkestein on behalf of the Commission

(30 January 2003)

The Commission can confirm that a letter of formal notice was sent at the end of October 2002 to
Sweden expressing the view that certain provisions in the Swedish Law on alcohol, according to which an
individual residing in Sweden cannot order alcoholic beverages for private use from producers or retailers
in other Member States and have them transported to Sweden, hinder intra-Community trade and may
therefore infringe Articles 28 and 30 of the EC Treaty.

Systembolaget has been granted responsibility for the retail sale of wine, strong beer and spirits in Sweden.
In the ‘Franzén’ case (Case C-189/95) the Court of Justice stated that, according to the information
provided to the Court, the existence and the operation of a domestic monopoly on retail of alcohol
beverages, such as Systembolaget, was compatible with Article 37 (now Article 31). However, the Court
continued and said that other provisions of the domestic legislation which, although not strictly speaking
regulating the functioning of the monopoly, nevertheless have a direct bearing upon it such as the
licensing system, should be examined with reference to Article 30 of the EC Treaty (now Article 28). In
order to comply with the Court’s judgement in relation to these paragraphs, several changes regarding the
licensing system were introduced in the Swedish legislation.