171.  As stated in paragraph 19, the Commission proposed that the legal base for the Regulation should be Article 95 of the E.C Treaty. This allows harmonisation of national laws affecting the establishment and functioning of the internal market. The Government's Explanatory Memorandum (EM)[68] took the view that Article 95 was not appropriate for measures which established a centralised EC procedural body. Other Articles, in particular Article 308 which is subject to unanimous voting, should be used.

172.  The EM also pointed out that the UK position on the use of Article 95 was being tested in two cases in the European Court of Justice. It added that the Department of Health would follow the procedure agreed with UK Law Officers where the UK supported proposals for policy reasons even though it was considered that the wrong legal base had been used.

173.  We asked for clarification of this statement and drew attention to our concern about other instances where the Government had supported proposals which it regarded as otherwise worthwhile, despite having reservations about the proposed legal base[69].

174.  The Minister replied[70] that, in the Government's view, setting up bodies or procedures at Community level did not amount to the harmonisation of national law, as provided for by Article 95, because it was outside the scope of national law. The Government had raised these objections with the Commission.

175.  The Minister also confirmed that the UK had mounted a legal challenge at the European Court of Justice to two other Regulations based on Article 95[71]. Until these challenges were resolved, the UK would continue to register concern about the inappropriate use of Article 95 by entering a Minute Statement recording disagreement with the legal base. That would not prejudice the UK's approach to future challenges under this Article. The UK Presidency would also work with partners to help ensure that measures were adopted using legitimate and appropriate legal bases.

176.  In subsequent correspondence[72], the Minister told us that Denmark and Portugal had registered similar reservations on the legal base. Other Member States might follow suit, but it was highly unlikely but enough would do so to affect the outcome of any vote on the proposed Directive.

177.  We replied[73] pointing out that the centralised body concerned in the Regulation would be the Paediatric Committee which would function under the aegis of the European Medicines Agency (EMEA). But we noted that the Government did not appear to have challenged the use of Article 95 as a legal base for the EMEA itself. We found that surprising and seemingly inconsistent with the challenges mentioned in earlier correspondence.

178.  In response the Minister[74] reiterated that the Government intended to record disagreement over the appropriateness of Article 95 in a Minute Statement at the Council. But the Government believed that it would not be desirable to oppose every measure which used Article 95 inappropriately where they supported the underlying policy while awaiting the outcome of two UK challenges at the European Court of Justice.

179.  Subsequently the Minister confirmed[75] that, when the Government voted in favour of setting up the European Medicines Agency in 2003, it had submitted a Minute Statement registering objection to the use of Article 95 as the proposed legal base.

180.  On 6 December 2005, the ECJ found against the UK in the case of United Kingdom v European Parliament and Council[76] and held that Article 95 was an appropriate legal base for a Regulation which laid down a Community procedure for authorising smoke flavourings. This judgment suggests that Article 95 can be used as the legal base for proposals which establish centralised procedures in certain circumstances. The question of whether Article 95 is appropriate for the creation of centralised body remains before the Court in a case concerning the creation of the European Network and Information Security Agency. A judgment is expected shortly.

181.  We are concerned about this and other instances where, in the Government's view, the Commission has proposed an inappropriate legal base, (including one where the Government's approach does not seem to be consistent[77]). We support the Government in taking a robust line where the Commission puts forward a proposal with a legal base which is controversial. The recent ruling in the smoke flavourings case shows that Article 95 may be appropriate in relation to certain aspects of the current proposal but the issue of whether Article 95 can be used to establish a centralised body remains before the Court.[78]

182.  In principle, we continue to believe that the Government should take a robust and consistent line in opposing proposals by the Commission which are, in the Government's view, brought forward on an inappropriate legal base. In this particular instance, in light of the overriding importance of the proposal and the need to make rapid progress in implementing it, we conclude that the Government is justified in agreeing to the present proposal with a Minute Statement recording its objection to the legal base.

69   pp 31-32 Back

70   pp 31-32 Back

71   Regulation (EC) 2065/2003 of 10 November 2003 on Smoke Flavouring used or intended for use in or on foods (Case 66/04 UK -v- Council and Parliament) and Regulation no 460/2004 of 10 March 2004 establishing the European Network and Information Security Agency (Case 217/04 UK-v- Council and Parliament) Back

72   pp 35-38 Back

73   pp 57-59 Back

74   pp 59-60 Back

75   pp 60-61 Back

76   Case 66/04 Back

77   In the case of the Proposal for a Regulation to establish a European Institute for Gender Equality (Commission reference 7244/05 COM (2005) 328)) the Government felt on balance that the Articles proposed (Articles 13 (2) and 141 (3) EC) were a sufficient legal base. But in the case of the Proposal for creation of European Monitoring Centre for Drugs and Drug Addiction (Commission reference 12143/05 COM (2005) 399 final), the Government took the view that the Article concerned (Article 152 (EC) was not appropriate. Back

78   Case 217/04 Back