COMMISSION DECISION of 20 May 1994 laying down detailed rules for the application of Council Directive 91/493/EEC, as regards own health checks on fishery products (Text with EEA relevance) (94/356/EC)
THE COMMISSION OF THE EUROPEAN  COMMUNITIES
,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 91/493/EEC of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products (1), and in particular Article 6 (3) thereof,
Whereas, in accordance with Article 6 (3) of the said Directive, rules must be laid down for the application of the principles on which own-checks are based; whereas it is necessary to define what is meant by the identification of critical points and  the establishment and implementation of methods for monitoring and checking such critical points;
Whereas laboratories must be approved by the competent authorities on equivalent terms in all the Member States;
Whereas keeping a written record or a record otherwise registered must entail keeping complete documentation containing all information relating to the establishment of own-checks and the results of those checks;
Whereas the design and introduction of own-checks will differ from one establishment to another; whereas it is therefore necessary to propose, in the form of guidelines, a model of a logical approach intended to facilitate the uniform application of
Article 6
(1) of Directive 91/493/EEC;
Whereas the measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,
1. 'Own-checks' as referred to in the second subparagraph of Article 6 (1) of Directive 91/493/EEC means all those actions aimed at ensuring and demonstrating that a fishery product satisfies the requirements of that Directive. Those actions  must correspond to an approach internal to the establishment; they must be developed and implemented by the persons responsible for each production unit, or under their management, in accordance with the general principles set out in the Annex hereto.
2. As part of the internal approach referred to in paragraph 1, establishments may use guides of good manufacturing practice drawn up by appropriate professional organizations and acceptable to the competent authorities.
3. The persons responsible for the establishment must ensure that all staff concerned by own-checks receive adequate training in order to effectively participate in their implementation.
1. 'Critical point' as referred to in the first indent of the second subparagraph of Article 6 (1) of Directive 91/493/EEC means any point, step or procedure at which control can be applied and a food safety hazard can be prevented,  eliminated or reduced to acceptable levels. All critical points which are useful for ensuring compliance with the hygiene requirements of that Directive must be identified.
For the purpose of identifying these critical points, Chapter I of the Annex hereto shall apply.
2. The critical points are specific to each establishment depending on the raw materials it uses and on its manufacturing processes, structures and equipment, end products and marketing system.
'Monitoring and checking such critical points' as referred to in the second indent of the second subparagraph of Article 6 (1) of Directive 91/493/EEC includes all those set observations and/or measurements necessary to ensure that critical  points are kept under control. Monitoring and checking critical points does not include verifying that end products conform with the standards laid down in Directive 91/493/EEC.
For the purpose of introducing and implementing monitoring and checking, Chapter II of the Annex hereto shall apply.
1. Sampling for laboratory analysis as referred to in the third indent of the second subparagraph of Article 6 (1) of Directive 91/493/EEC is intended to confirm that the own-checks system complies effectively with Articles 1, 2 and 3 of this  Decision.
2. The persons responsible for the establishment must make provision for a sampling programme which, though not concerning systematically every production batch, nevertheless allows:
(a) validation of the own-checks system when first set up;
(b) if necessary, revalidation of the system in case of a change to the characteristics of the product or to the manufacturing process;
(c) verification, at specified intervals, that all provisions are still appropriate and properly applied.
3. Own-checks system shall be confirmed in accordance with the provisions set out in Chapter III of the Annex.
For the approval of laboratories mentioned in the third indent of the second subparagraph of Article 6 (1) of Directive 91/493/EEC, the competent authorities of the Member States shall take into account the requirements of EN 45 001 standards  or equivalent requirements. However, for the approval of establishments' internal laboratories, the competent authorities may base themselves on less restrictive principles inspired by the relevent points in Annex B to Council Directive 88/320/EEC (2).
1. In order to keep 'a written record or a record registered in an indelible fashion', as referred to in the fourth indent of the second subparagraph of Article 6 (1) of Directive 91/493/EEC, the persons responsible for the establishment must  document all information relating to the implementation of own-checks and their verification.
2. The documentation referred to in paragraph 1 must include two types of information to be kept for submission to the competent authority:
(a) a detailed and comprehensive document including:
- description of the product,
- description of the manufacturing process indicating critical points,
- for each critical point, identified hazards, assessment of risks and control measures,
- procedures for monitoring and checking at each such critical point, with indication of critical limits for parameters that need to be controlled and corrective action to be taken in case of loss of control,
- procedures for verification and review.
In the case provided for in Article 1 (2), this document may be the guide of good practice drawn up by the professional organization concerned.
(b) records of the observations and/or measurements referred to in Article 3, results of the verification activities referred to in Article 4, reports and written accounts of decisions relating to corrective action when taken. An appropriate document  management system must provide, in particular, for the easy retrieval of all documents relating to an identified production batch.
The competent authorities shall ensure appropriate training of inspection staff authorized to perform official checks to allow them to assess the own-checks system set up by the persons responsible for the establishment on the basis of the  documents submitted.
Member States shall inform the Commission of any difficulties in the application of this Decision which will be reviewed one year following its adoption, in the light of experience acquired.
This Decision is addressed to the Member States.