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Life Sciences: Legislative Updates

Consolidation of Cosmetics Rules

The cosmetics industry is currently regulated in the EU by the Cosmetics Directive (76/778/EEC) together with several amending Directives which have been enacted since. This legislation is set to change dramatically in the next few years following the adoption of Regulation 1223/2009 in late 2009.

In order for the cosmetic industry to have time to comply with the provisions of the new Regulation, the majority of the provisions will not come into force until 11 July 2013, however Articles 15(1) and 15 (2) relating to Carcinogenic, Mutagenic or Reproductively Toxic substances came into force 1 December 2010 while further provisions will take effect on 11 January 2013.

The main changes relate to:

  • New definitions
  • Simplified notification procedures
  • Introduction of Cosmetic Products Safety Assessment
  • New safety rules in relation to certain types of substances
  • Enhancement of in-market control

Pharmaceutical Package

The European Commission has proposed new legislation in respect of three important aspects of the pharmaceutical industry. These proposals, in the form of draft Directives, are collectively known as the “Pharmaceutical Package”.

The three issues dealt with in the package are:

  • Tackling the counterfeiting and illegal distribution of medicines
  • Ensuring patients receive the highest possible quality of information on prescription medication
  • Strengthening the safety monitoring system of medicines

These are issues which need to be addressed at the European level to ensure that, in a period of increased globalisation in this sector, the European pharmaceutical industry remains competitive and that patients continue to receive the highest possible standard of medicine.

The proposals will be discussed and debated in greater detail by the European institutions and it is likely that there will be amendments before the legislation is eventually passed.

Food Labelling

A draft European Regulation, which received ministerial agreement on 7 December last, is moving through the EU legislative process, the purpose of which is to consolidate and amend the current legislation dealing with food labelling. One of the issues currently being debated by the European Parliament and Commission is the way information should be displayed on food packaging.

The aim of the proposed legislation is to adopt a uniform application of food labels throughout the EU. Once passed, the proposed legislation will require front-of-packet nutritional labelling, the format of which continues to be hotly debated. Early drafts of the Regulation suggested that a colour coding system was considered however the European Parliament has rejected the possibility of adopting such a system.

Whatever format for food labelling is decided upon, food manufacturers will probably need to redesign their food packaging to ensure compliance with this legislation. It has been suggested within the draft legislation that businesses will be given time to implement such changes. Smaller companies, defined as companies employing less than a hundred people and having an annual turnover of less than €5 million, will be given 5 years to redesign their packaging, if necessary. Larger companies will need to comply with the new rules within 3 years of the Regulation coming into force.