Commission Directive 2012/39/EU of 26 November 2012 amending Directive 2006/17/EC as regards certain technical requirements for the testing of human tissues and cells Text with EEA relevance

Directive 2012/39/EU · Directive · 5 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

Annexes II and III to Directive 2006/17/EC are amended in accordance with the Annex to this Directive.

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 17 June 2014 at the latest. They shall forthwith communicate to the Commission the text of those provisions. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Article 4

This Directive is addressed to the Member States.

Supplementary provisions

ANNEXSupplementary provisions

ANNEX Annexes II and III to Directive 2006/17/EC are amended as follows: (1) in Annex II, point 1.2 is replaced by the following: ‘1.2. HTLV-I antibody testing must be performed for donors living in, or originating from, high-prevalence areas or with sexual partners originating from those areas or where the donor’s parents originate from those areas’; (2) Annex III is amended as follows: (a) point 2.4 is replaced by the following: ‘2.4. HTLV-I antibody testing must be performed for donors living in, or originating from, high-prevalence areas or with sexual partners originating from those areas or where the donor’s parents originate from those areas’; (b) point 3.3 is replaced by the following: ‘3.3. HTLV-I antibody testing must be performed for donors living in, or originating from, high-prevalence areas or with sexual partners originating from those areas or where the donor’s parents originate from those areas’; (c) point 4.2 is replaced by the following: ‘4.2. For donations other than by partners, blood samples must be obtained at the time of each donation. For donation by partners (not for direct use), blood samples must be obtained within three months before the first donation. For further partner donations by the same donor, further blood samples must be obtained according to national legislation, but no later than 24 months from the previous sampling.’.

Implementing measures in the Member States

Transposition links come from the Member States’ notifications published on EUR-Lex. Only high-confidence matches held on LawPlayer are listed; see EUR-Lex for the complete list.

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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