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32000L0006

Twenty-fourth Commission Directive 2000/6/EC of 29 February 2000 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance)

Official Journal L 056 , 01/03/2000 P. 0042 - 0046

TWENTY-FOURTH COMMISSION DIRECTIVE 2000/6/ECof 29 February 2000adapting to technical progress Annexes II, III, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(1), as last amended by Commission Directive 98/62/EC(2), and in particular Article 8(2) thereof,After consulting the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers,Whereas:(1) Tallow derivatives, such as fatty acids, glycerine, esters of fatty acids and soaps and fatty alcohols, fatty amines and fatty amides derived therefrom, are considered safe for use in the manufacture of cosmetic products with regard to the risk of contracting transmissible spongiform encephalopathies if they are prepared in strict accordance with specific physico-chemical processes in which temperature is the decisive parameter on which the corresponding pressure conditions depend. Annex II to the abovementioned Directive should therefore be amended accordingly.(2) Harmful secondary effects have been shown to arise following prolonged use of hydroquinone as skin-lightening cream. This particular use of hydroquinone must not therefore be authorised, meaning that Part I of Annex III to the abovementioned Directive needs to be amended. Studies also show that the concentration of hydroquinone used in hair dyes does not have harmful effects for health if it does not exceed 0,3 %. Part I of Annex III to the abovementioned Directive must be amended accordingly.(3) On the basis of new scientific data, benzalkonium chloride, bromide and saccharinate have recently been added to the list of substances which may be used as preservatives in the manufacture of cosmetic products set out in Part 1 of Annex VI to the abovementioned Directive. In the light of experience, it is also acceptable for these benzalkonium salts to be used for other purposes in cosmetic products, according to the length of their carbon chain, provided that the maximum authorised concentrations are observed. These specific characteristics therefore justify their inclusion in the list Part 1 of Annex III.(4) The cosmetics industry has supplied new scientific data based on studies of the percutaneous absorption of acqueous solutions of boric acid, borates and tetraborates at various pH numbers and at various concentrations showing that the requirement that pH should be neutral or slightly alkaline in order to minimise the percutaneous absorption of these boron derivatives is not justified. The list of substances which cosmetic products must not contain except subject to the restrictions and conditions laid down, set out in Part 1 of Annex III, should therefore be amended accordingly.(5) In the concentrations in which it is normally used as a preservative in cosmetic products intended to be removed by rinsing, benzylhemiformal is not likely to cause harmful effects for human health. Therefore it should be removed from Part 2 of Annex VI to the abovementioned Directive which sets out the list of preservatives provisionally allowed in cosmetic products and included in Part 1 of Annex VI which contains the list of preservatives allowed in cosmetic products.(6) In the concentrations in which it is normally used as a preservative in cosmetic products, 3-iodo-2-propynyl butylcarbamate is not likely to have harmful effects on human health. Therefore, it should be removed from the list in Part 2 of Annex VI and entered in the list in Part 1 of Annex VI.(7) In the concentrations in which it is normally used as a UV filter for sunscreen cream, 4-dimethyl-amino-benzoate of ethyl-2-hexyl (octyl dimethyl PABA) is not likely to have harmful effects on the health of users. Therefore, it should be removed from Part 2 of Annex VII to the abovementioned Directive which sets out the list of UV filters that cosmetic products may provisionally contain and entered in Part 1 of Annex VII which contains the list of UV filters allowed in cosmetic products.(8) In the concentrations in which it is normally used as a UV filter for sunscreen cream, 2-hydroxy-4-methoxybenzophenone-5-sulfonic acid (benzophenone-5) and its sodium salt is not likely to give rise to harmful effects for human health. Therefore, 2-hydroxy-4-methoxybenzophenone-5-sulfonic (benzophenone-5) and its sodium salt should be removed from Part 2 of Annex VII and entered in Part 1 of Annex VII.(9) 4-isopropyl-benzyl salicylate is no longer used as a UV filter for sunscreen products. Consequently, 4-isopropyl-benzyl salicylate must be removed from Part 2 of Annex VII.(10) Within the concentration limits and under the conditions adopted by the cosmetic industry for its use as a UV filter for sunscreen products, 2,2'-methylene-bis-6-(2H-benzotriazol-2-yl)-4-tetra-methyl-butyl-1,1,3,3-phenol, is not likely to produce harmful effects for the health of users. Therefore, it may be included in the list in Part 1 of Annex VII.(11) Within the concentration limits and under the conditions adopted by the cosmetic industry for its use as a UV filter for sunscreen products, the monosodium salt of 2-2'-bis-(1,4-phenylene)1H-benzimidazole-4,6-disulfonic acid is not likely to have harmful effects on the health of users. Therefore, it may be included in the list in Part 1 of Annex VII.(12) Within the concentration limits and under the conditions adopted by the cosmetic industry for its use as a UV filter for sunscreen products, (1,3,5)-triazine-2,4-bis-((4-(2-ethyl-hexyloxy)-2-hydroxy)-phenyl)-6-(4-methoxyphenyl) is not likely to have harmful effects on the health of users. Therefore, it may be included in the list in Part 1 of Annex VII.(13) The measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector,HAS ADOPTED THIS DIRECTIVE:Article 1Directive 76/768/EEC is hereby amended as indicated in the Annex to this Directive.Article 2Member States shall adopt the necessary measures to ensure that cosmetic products containing the substances listed in Annexes II, III, VI and VII to Directive 76/768/EEC, as set out in the Annex to this Directive, which are supplied to the final consumer after 1 January 2001, comply with the provisions of this Directive.Article 3Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 2000 at the latest. They shall forthwith inform the Commission thereof.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.Article 4This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Communities.Article 5This Directive is addressed to the Member States.Done at Brussels, 29 February 2000.For the CommissionErkki LIIKANENMember of the Commission(1) OJ L 262, 27.9.1976, p. 169.(2) OJ L 253, 15.9.1998, p. 20.ANNEXThe Annexes to Directive 76/768/EEC are hereby amended as follows:1. In Annex IIThe first indent of paragraph (b) of reference number 419 reads as follows: "- transesterification or hydrolysis at at least 200 °C and at an appropriate corresponding pressure, for 20 minutes (glycerol, fatty acids and fatty acid esters),"2. In Part 1 of Annex III(i) Reference number 1 is amended as shown in the following table: ">TABLE>"(ii) Reference number 14 is hereby amended as follows:- the second occurrence of "Hydroquinone" in column b, item "(b)" in column c, the second occurrence of "2 %" in column (d) and item "(b)" in column f are deleted,- "2 %" in column d is replaced by "0,3 %".(iii) Reference number 65 is added in accordance with the following table: ">TABLE>"3. In Annex VI(i) The following reference numbers are added in Part 1: ">TABLE>"(ii) Reference numbers 21 and 29 in Part 2 are deleted.4. In Annex VII(i) The following reference numbers are added in Part 1: ">TABLE>"(ii) Reference numbers 5, 17 and 29 in Part 2 are deleted.


title: Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments   (Text with EEA relevance)

text:
               1.10.2005

               EN

               Official Journal of the European Union

               L 256/41

      COMMISSION DIRECTIVE 2005/62/EC
   of 30 September 2005
   implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (1), and in particular point (h) of the second paragraph of Article 29 thereof,
   Whereas:

               (1)

               Directive 2002/98/EC lays down standards of quality and safety for the collection and testing of human blood and blood components, whatever their intended purpose, and for their processing, storage and distribution when intended for transfusion so as to ensure a high level of human health protection.

               (2)

               In order to prevent the transmission of diseases by blood and blood components and to ensure an equivalent level of quality and safety, Directive 2002/98/EC calls for the establishment of specific technical requirements including Community standards and specifications with regard to a quality system for blood establishments.

               (3)

               A quality system for blood establishments should embrace the principles of quality management, quality assurance, and continuous quality improvement, and should include personnel, premises and equipment, documentation, collection, testing and processing, storage and distribution, contract management, non-conformance and self-inspection, quality control, blood component recall, and external and internal auditing.

               (4)

               This Directive lays down those technical requirements, which take account of Council Recommendation 98/463/EC of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community (2), Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (3), Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (4), Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (5), certain recommendations of the Council of Europe, the monographs of the European Pharmacopoeia, particularly in respect of blood or blood components as a starting material for the manufacture of proprietary medicinal products, recommendations of the World Health Organisation, as well as international experience in this field.

               (5)

               In order to ensure the highest quality and safety for blood and blood components, guidance on good practice should be developed to support the quality system requirements for blood establishments taking fully into account the detailed guidelines referred to in Article 47 of Directive 2001/83/EC so as to ensure that the standards required for medicinal products are maintained.

               (6)

               Blood and blood components imported from third countries, including those used as starting material or raw material for the manufacture of medicinal products derived from human blood and human plasma intended for distribution in the Community, should meet equivalent Community standards and specifications relating to a quality system for blood establishments as set out in this Directive.

               (7)

               It is necessary to specify that a quality system is to be applied for any blood and blood components circulating in the Community and that Member States therefore should ensure that for blood and blood components coming from third countries there is a quality system in place for blood establishments in the stages preceding importation equivalent to the quality system provided under this Directive.

               (8)

               It is necessary to determine common definitions for technical terminology in order to ensure the consistent implementation of Directive 2002/98/EC.

               (9)

               The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Directive 2002/98/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Definitions
   For the purposes of this Directive, the following definitions shall apply:

               (a)

               ‘standard’ means the requirements that serve as the basis for comparison;

               (b)

               ‘specification’ means a description of the criteria that must be fulfilled in order to achieve the required quality standard;

               (c)

               ‘quality system’ means the organisational structure, responsibilities, procedures, processes, and resources for implementing quality management;

               (d)

               ‘quality management’ means the co-ordinated activities to direct and control an organisation with regard to quality at all levels within the blood establishment;

               (e)

               ‘quality control’ means part of a quality system focussed on fulfilling quality requirements;

               (f)

               ‘quality assurance’ means all the activities from blood collection to distribution made with the object of ensuring that blood and blood components are of the quality required for their intended use;

               (g)

               ‘trace-back’ means the process of investigating a report of a suspected transfusion-associated adverse reaction in a recipient in order to identify a potentially implicated donor;

               (h)

               ‘written procedures’ means controlled documents that describe how specified operations are to be carried out;

               (i)

               ‘mobile site’ means a temporary or movable place used for the collection of blood and blood components which is in a location outside of but under the control of the blood establishment;

               (j)

               ‘processing’ means any step in the preparation of a blood component that is carried out between the collection of blood and the issuing of a blood component;

               (k)

               ‘good practice’ means all elements in established practice that collectively will lead to final blood or blood components that consistently meet predefined specifications and compliance with defined regulations;

               (l)

               ‘quarantine’ means the physical isolation of blood components or incoming materials/reagents over a variable period of time while awaiting acceptance, issuance or rejection of the blood components or incoming materials/reagents;

               (m)

               ‘validation’ means the establishment of documented and objective evidence that the pre-defined requirements for a specific procedure or process can be consistently fulfilled;

               (n)

               ‘qualification’, as part of validation, means the action of verifying that any personnel, premises, equipment or material works correctly and delivers the expected results;

               (o)

               ‘computerised system’ means a system including the input of data, electronic processing and the output of information to be used either for reporting, automatic control or documentation.

         Article 2
   Quality system standards and specifications
   1.   Member States shall ensure that the quality system in place in all blood establishments complies with the Community standards and specifications set out in the Annex to this Directive.
   2.   Good practice guidelines shall be developed by the Commission, in accordance with Article 28 of Directive 2002/98/EC, for the interpretation of the Community standards and specifications referred to in paragraph 1. When developing these guidelines, the Commission shall take fully into account the detailed principles and guidelines of good manufacturing practice, as referred to in Article 47 of Directive 2001/83/EC.
   3.   Member States shall ensure that for blood and blood components imported from third countries and intended for use or distribution in the Community, there is a quality system for blood establishments in the stages preceding importation equivalent to the quality system provided for in Article 2.
   Article 3
   Transposition
   1.   Without prejudice to Article 7 of Directive 2002/98/EC, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 August 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   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 4
   Entry into force
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 5
   Addressees
   This Directive is addressed to the Member States.

      Done at Brussels, 30 September 2005.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 33, 8.2.2003, p. 30.

      (2)  OJ L 203, 21.7.1998, p. 14.

      (3)  OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, p. 34).

      (4)  OJ L 262, 14.10.2003, p. 22.

      (5)  OJ L 91, 30.3.2004, p. 25.

      ANNEX
      Quality system standards and specifications
      1.   INTRODUCTION AND GENERAL PRINCIPLES
      1.1.   Quality system

                  1.

                  Quality shall be recognised as being the responsibility of all persons involved in the processes of the blood establishment with management ensuring a systematic approach towards quality and the implementation and maintenance of a quality system.

                  2.

                  The quality system encompasses quality management, quality assurance, continuous quality improvement, personnel, premises and equipment, documentation, collection, testing and processing, storage, distribution, quality control, blood component recall, and external and internal auditing, contract management, non-conformance and self-inspection.

                  3.

                  The quality system shall ensure that all critical processes are specified in appropriate instructions and are carried out in accordance with the standards and specifications set out in this Annex. Management shall review the system at regular intervals to verify its effectiveness and introduce corrective measures if deemed necessary.

            1.2.   Quality assurance

                  1.

                  All blood establishments and hospital blood banks shall be supported by a quality assurance function, whether internal or related, in fulfilling quality assurance. That function shall be involved in all quality-related matters and review and approve all appropriate quality related documents.

                  2.

                  All procedures, premises, and equipment that have an influence on the quality and safety of blood and blood components shall be validated prior to introduction and be re-validated at regular intervals determined as a result of these activities.

            2.   PERSONNEL AND ORGANISATION

                  1.

                  Personnel in blood establishments shall be available in sufficient numbers to carry out the activities related to the collection, testing, processing, storage and distribution of blood and blood components and be trained and assessed to be competent to perform their tasks.

                  2.

                  All personnel in blood establishments shall have up to date job descriptions which clearly set out their tasks and responsibilities. Blood establishments shall assign the responsibility for processing management and quality assurance to different individuals and who function independently.

                  3.

                  All personnel in blood establishments shall receive initial and continued training appropriate to their specific tasks. Training records shall be maintained. Training programmes shall be in place and shall include good practice.

                  4.

                  The contents of training programmes shall be periodically assessed and the competence of personnel evaluated regularly.

                  5.

                  There shall be written safety and hygiene instructions in place adapted to the activities to be carried out and are in compliance with Council Directive 89/391/EEC (1) and Directive 2000/54/EC of the European Parliament and of the Council (2).

            3.   PREMISES
      3.1.   General
      Premises including mobile sites shall be adapted and maintained to suit the activities to be carried out. They shall enable the work to proceed in a logical sequence so as to minimise the risk of errors, and shall allow for effective cleaning and maintenance in order to minimise the risk of contamination.
      3.2.   Blood donor area
      There shall be an area for confidential personal interviews with and assessment of individuals to assess their eligibility to donate. This area shall be separated from all processing areas.
      3.3.   Blood collection area
      Blood collection shall be carried out in an area intended for the safe withdrawal of blood from donors, appropriately equipped for the initial treatment of donors experiencing adverse reactions or injuries from events associated with blood donation, and organised in such a way as to ensure the safety of both donors and personnel as well as to avoid errors in the collection procedure.
      3.4.   Blood testing and processing areas
      There shall be a dedicated laboratory area for testing that is separate from the blood donor and blood component processing area with access restricted to authorised personnel.
      3.5.   Storage area

                  1.

                  Storage areas shall provide for properly secure and segregated storage of different categories of blood and blood components and materials including quarantine and released materials and units of blood or blood components collected under special criteria (e.g. autologous donation).

                  2.

                  Provisions shall be in place in the event of equipment or power failure in the main storage facility.

            3.6.   Waste disposal area
      An area shall be designated for the safe disposal of waste, disposable items used during the collection, testing, and processing and for rejected blood or blood components.
      4.   EQUIPMENT AND MATERIALS

                  1.

                  All equipment shall be validated, calibrated and maintained to suit its intended purpose. Operating instructions shall be available and appropriate records kept.

                  2.

                  Equipment shall be selected to minimise any hazard to donors, personnel, or blood components.

                  3.

                  Only reagents and materials from approved suppliers that meet the documented requirements and specifications shall be used. Critical materials shall be released by a person qualified to perform this task. Where relevant, materials, reagents and equipment shall meet the requirements of Council Directive 93/42/EEC (3) for medical devices and Directive 98/79/EC of the European Parliament and of the Council (4) for in vitro diagnostic medical devices or comply with equivalent standards in the case of collection in third countries.

                  4.

                  Inventory records shall be retained for a period acceptable to and agreed with the competent authority.

                  5.

                  When computerised systems are used, software, hardware and back-up procedures must be checked regularly to ensure reliability, be validated before use, and be maintained in a validated state. Hardware and software shall be protected against unauthorised use or unauthorised changes. The back-up procedure shall prevent loss of or damage to data at expected and unexpected down times or function failures.

            5.   DOCUMENTATION

                  1.

                  Documents setting out specifications, procedures and records covering each activity performed by the blood establishment shall be in place and kept up to date.

                  2.

                  Records shall be legible and may be handwritten, transferred to another medium such as microfilm or documented in a computerised system.

                  3.

                  All significant changes to documents shall be acted upon promptly and shall be reviewed, dated and signed by a person authorised to perform this task.

            6.   BLOOD COLLECTION, TESTING AND PROCESSING
      6.1.   Donor eligibility

                  1.

                  Procedures for safe donor identification, suitability interview and eligibility assessment shall be implemented and maintained. They shall take place before each donation and comply with the requirements set out in Annex II and Annex III to Directive 2004/33/EC.

                  2.

                  The donor interview shall be conducted in such a way as to ensure confidentiality.

                  3.

                  The donor suitability records and final assessment shall be signed by a qualified health professional.

            6.2.   Collection of blood and blood components

                  1.

                  The blood collection procedure shall be designed to ensure that the identity of the donor is verified and securely recorded and that the link between the donor and the blood, blood components and blood samples is clearly established.

                  2.

                  The sterile blood bag systems used for the collection of blood and blood components and their processing shall be CE-marked or comply with equivalent standards if the blood and blood components are collected in third countries. The batch number of the blood bag shall be traceable for each blood component.

                  3.

                  Blood collection procedures shall minimise the risk of microbial contamination.

                  4.

                  Laboratory samples shall be taken at the time of donation and appropriately stored prior to testing.

                  5.

                  The procedure used for the labelling of records, blood bags and laboratory samples with donation numbers shall be designed to avoid any risk of identification error and mix-up.

                  6.

                  After blood collection, the blood bags shall be handled in a way that maintains the quality of the blood and at a storage and transport temperature appropriate to further processing requirements.

                  7.

                  There shall be a system in place to ensure that each donation can be linked to the collection and processing system into which it was collected and/or processed.

            6.3.   Laboratory testing

                  1.

                  All laboratory testing procedures shall be validated before use.

                  2.

                  Each donation shall be tested in conformity with the requirements laid down in Annex IV to Directive 2002/98/EC.

                  3.

                  There shall be clearly defined procedures to resolve discrepant results and ensure that blood and blood components that have a repeatedly reactive result in a serological screening test for infection with the viruses mentioned in Annex IV to Directive 2002/98/EC shall be excluded from therapeutic use and be stored separately in a dedicated environment. Appropriate confirmatory testing shall take place. In case of confirmed positive results, appropriate donor management shall take place including the provision of information to the donor and follow-up procedures.

                  4.

                  There shall be data confirming the suitability of any laboratory reagents used in the testing of donor samples and blood component samples.

                  5.

                  The quality of the laboratory testing shall be regularly assessed by the participation in a formal system of proficiency testing, such as an external quality assurance programme.

                  6.

                  Blood group serology testing shall include procedures for testing specific groups of donors (e.g. first time donors, donors with a history of transfusion).

            6.4.   Processing and validation

                  1.

                  All equipment and technical devices shall be used in accordance with validated procedures.

                  2.

                  The processing of blood components shall be carried out using appropriate and validated procedures including measures to avoid the risk of contamination and microbial growth in the prepared blood components.

            6.5.   Labelling

                  1.

                  At all stages, all containers shall be labelled with relevant information of their identity. In the absence of a validated computerised system for status control, the labelling shall clearly distinguish released from non-released units of blood and blood components.

                  2.

                  The labelling system for the collected blood, intermediate and finished blood components and samples must unmistakably identify the type of content, and comply with the labelling and traceability requirements referred to in Article 14 of Directive 2002/98/EC and Commission Directive 2005/61/EC (5). The label for a final blood component shall comply with the requirements of Annex III to Directive 2002/98/EC.

                  3.

                  For autologous blood and blood components, the label also shall comply with Article 7 of Directive 2004/33/EC and the additional requirements for autologous donations specified in Annex IV to that Directive.

            6.6.   Release of blood and blood components

                  1.

                  There shall be a safe and secure system to prevent each single blood and blood component from being released until all mandatory requirements set out in this Directive have been fulfilled. Each blood establishment shall be able to demonstrate that each blood or blood component has been formally released by an authorised person. Records shall demonstrate that before a blood component is released, all current declaration forms, relevant medical records and test results meet all acceptance criteria.

                  2.

                  Before release, blood and blood components shall be kept administratively and physically segregated from released blood and blood components. In the absence of a validated computerised system for status control the label of a unit of blood or blood component shall identify the release status in accordance with 6.5.1.

                  3.

                  In the event that the final component fails release due to a confirmed positive infection test result, in conformity with the requirements set out in Section 6.3.2 and 6.3.3, a check shall be made to ensure that other components from the same donation and components prepared from previous donations given by the donor are identified. There shall be an immediate update of the donor record.

            7.   STORAGE AND DISTRIBUTION

                  1.

                  The quality system of the blood establishment shall ensure that, for blood and blood components intended for the manufacture of medicinal products, the storage and distribution requirements shall comply with Directive 2003/94/EC.

                  2.

                  Procedures for storage and distribution shall be validated to ensure blood and blood component quality during the entire storage period and to exclude mix-ups of blood components. All transportation and storage actions, including receipt and distribution, shall be defined by written procedures and specifications.

                  3.

                  Autologous blood and blood components as well as blood components collected and prepared for specific purposes shall be stored separately.

                  4.

                  Appropriate records of inventory and distribution shall be kept.

                  5.

                  Packaging shall maintain the integrity and storage temperature of blood or blood components during distribution and transportation.

                  6.

                  Return of blood and blood components into inventory for subsequent reissue shall only be accepted when all quality requirements and procedures laid down by the blood establishment to ensure blood component integrity are fulfilled.

            8.   CONTRACT MANAGEMENT
      Tasks that are performed externally shall be defined in a specific written contract.
      9.   NON-CONFORMANCE
      9.1.   Deviations
      Blood components deviating from required standards set out in Annex V to Directive 2004/33/EC shall be released for transfusion only in exceptional circumstances and with the recorded agreement of the prescribing physician and the blood establishment physician.
      9.2.   Complaints
      All complaints and other information, including serious adverse reactions and serious adverse events, which may suggest that defective blood components have been issued, shall be documented, carefully investigated for causative factors of the defect and, where necessary, followed by recall and the implementation of corrective actions to prevent recurrence. Procedures shall be in place to ensure that the competent authorities are notified as appropriate of serious adverse reactions or serious adverse events in accordance with regulatory requirements.
      9.3.   Recall

                  1.

                  There shall be personnel authorised within the blood establishment to assess the need for blood and blood component recall and to initiate and coordinate the necessary actions.

                  2.

                  An effective recall procedure shall be in place, including a description of the responsibilities and actions to be taken. This shall include notification to the competent authority.

                  3.

                  Actions shall be taken within pre-defined periods of time and shall include tracing all relevant blood components and, where applicable, shall include trace-back. The purpose of the investigation is to identify any donor who might have contributed to causing the transfusion reaction and to retrieve available blood components from that donor, as well as to notify consignees and recipients of components collected from the same donor in the event that they might have been put at risk.

            9.4.   Corrective and preventive actions

                  1.

                  A system to ensure corrective and preventive actions on blood component non-conformity and quality problems shall be in place.

                  2.

                  Data shall be routinely analysed to identify quality problems that may require corrective action or to identify unfavourable trends that may require preventive action.

                  3.

                  All errors and accidents shall be documented and investigated in order to identify system problems for correction.

            10.   SELF-INSPECTION, AUDITS AND IMPROVEMENTS

                  1.

                  Self-inspection or audit systems shall be in place for all parts of the operations to verify compliance with the standards set out in this Annex. They shall be carried out regularly by trained and competent persons in an independent way according to approved procedures.

                  2.

                  All results shall be documented and appropriate corrective and preventive actions shall be taken in a timely and effective manner.

         (1)  OJ L 183, 29.6.1989, p. 1.

         (2)  OJ L 262, 17.10.2000, p. 21.

         (3)  OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

         (4)  OJ L 331, 7.12.1998, p. 1. Directive as amended by Regulation (EC) No 1882/2003.

         (5)  See page 32 of this Official Journal.


title: Commission Directive 2006/61/EC of  7 July 2006  amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for atrazine, azinphos-ethyl, cyfluthrin, ethephon, fenthion, methamidophos, methomyl, paraquat and triazophos   (Text with EEA relevance)

text:
               27.7.2006

               EN

               Official Journal of the European Union

               L 206/12

      COMMISSION DIRECTIVE 2006/61/EC

   of 7 July 2006
   amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for atrazine, azinphos-ethyl, cyfluthrin, ethephon, fenthion, methamidophos, methomyl, paraquat and triazophos
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (1), and in particular Article 10 thereof,
   Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin (2), and in particular Article 10 thereof,
   Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (3), and in particular Article 7 thereof,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (4), and in particular Article 4(1)(f) thereof,
   Whereas:

               (1)

               In the case of cereals and products of plant origin including fruit and vegetables, residue levels reflect the use of minimum quantities of pesticides necessary to achieve effective protection of plants, applied in such a manner that the amount of residue is as low as is practicable and toxicologically acceptable, having regard, in particular to the protection of the environment and the estimated dietary intake of consumers. In the case of foodstuffs of animal origin, residue levels reflect the consumption by animals of cereals and products of plant origin treated with pesticides and, where relevant, the direct consequences of the use of veterinary medicines. Community maximum residue levels (MRLs) represent the upper limit of the amount of such residues that might be expected to be found in commodities when good agricultural practices have been respected.

               (2)

               MRLs for pesticides are kept under review and changed to take account of new information and data. MRLs are fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residue in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported by the necessary data.

               (3)

               The Commission was informed that for several pesticides current MRLs may need to be revised in the light of the availability of new information on the toxicology and consumer intake. The Commission has asked the relevant rapporteur Member States to make proposals for the review of Community MRLs. Such proposals were submitted to the Commission.

               (4)

               The lifetime and short-term exposure of consumers to the pesticides referred to in this Directive via food products has been reassessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organization (5). On that basis, it is appropriate to fix new MRLs, which will ensure that there is no unacceptable consumer exposure.

               (5)

               Where relevant, the acute exposure of consumers to those pesticides via each of the food products that may contain residues has been assessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organization. It is concluded that the presence of pesticide residues at or below the new MRLs will not cause acute toxic effects.

               (6)

               Through the World Trade Organization, the Community’s trading partners have been consulted about the new MRLs and their comments on these levels have been taken into account.

               (7)

               The Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly.

               (8)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex II to Directive 86/362/EEC is amended in accordance with Annex I to this Directive.
   Article 2
   Annex II to Directive 86/363/EEC is amended in accordance with Annex II to this Directive.
   Article 3
   Annex II to Directive 90/642/EEC is amended in accordance with Annex III to this Directive.
   Article 4
   1.   Member States shall adopt and publish, by 20 January 2007 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 21 January 2007.
   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 5
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 7 July 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2006/59/EC (OJ L 175, 29.6.2006, p. 61).

      (2)  OJ L 221, 7.8.1986, p. 43. Directive as last amended by Commission Directive 2006/59/EC.

      (3)  OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2006/59/EC.

      (4)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/45/EC (OJ L 130, 18.5.2006, p. 27).

      (5)  Guidelines for predicting dietary intake of pesticide residues (revised), prepared by the GEMS/Food Programme in collaboration with the Codex Committee on Pesticide Residues, published by the World Health Organization 1997 (WHO/FSF/FOS/97.7).

      ANNEX I
      Part A of Annex II to Directive 86/362/EEC is amended as follows:

                  1.

                  The following line for atrazine is added:

                              Pesticide residues

                              Maximum level in mg/kg

                              ‘Atrazine

                              0,05 (1)

                              CEREALS

                  2.

                  The lines for azinphos-ethyl, ethephon and triazophos are replaced by the following:

                              Pesticide residues

                              Maximum level in mg/kg

                              ‘Azinphos-ethyl

                              0,05 (2)

                              CEREALS

                              Ethephon

                              0,5 barley, rye
                              0,2 triticale, wheat
                              0,05 (2) cereals others

                              Triazophos

                              0,02 (2)

                              CEREALS

         (1)  Indicates lower limit of analytical determination.’

         (2)  Indicates lower limit of analytical determination.’

      ANNEX II
      Part A of Annex II to Directive 86/363/EEC is amended as follows:

                  1.

                  In Part A of Annex II to Directive 86/363/EEC, the lines for azinphos-ethyl and triazophos are replaced by the following:

                              Pesticide residues

                              Maximum level in mg/kg

                              of fat contained in meat, preparations of meat, offal and animal fats listed in Annex I under headings Nos ex 0201, 0202, 0203, 0204, 0205 00 00, 0206, 0207, ex 0208, 0209 00, 0210, 1601 00 and 1602 (1) (4)

                              for cow's milk and whole cream cow's milk listed in Annex I under headings No 0401: for other foodstuffs in heading Nos 0401, 0402, 0405 00 and 0406 in accordance with (2) (4)

                              of shelled fresh eggs, for bird's eggs and egg yolks listed in Annex I under headings Nos 0407 00 and 0408 (3) (4)

                              ‘Azinphos-ethyl

                              0,01 (1)

                              0,01 (1)

                              0,01 (1)

                              Triazophos

                              0,01 (1)

                              0,01 (1)

                              0,01 (1)

                  2.

                  In Part A of Annex II to Directive 86/363/EEC, the line for fenthion is added by the following:

                              Pesticide residues

                              Maximum level in mg/kg

                              of fat contained in meat, preparations of meat, offal and animal fats listed in Annex I under headings Nos ex 0201, 0202, 0203, 0204, 0205 00 00, 0206, 0207, ex 0208, 0209 00, 0210, 1601 00 and 1602 (1) (4)

                              for cow's milk and whole cream cow's milk listed in Annex I under headings No 0401: for other foodstuffs in heading Nos 0401, 0402, 0405 00 and 0406 in accordance with (2) (4)

                              of shelled fresh eggs, for bird's eggs and egg yolks listed in Annex I under headings Nos 0407 00 and 0408 (3) (4)

                              ‘Fenthion and its oxygen analogue, their sulfoxides and sulfones expressed as parent

                              0,05 (2)

                              0,01 (2)

                              —

         (1)  Indicates lower limit of analytical determination.’

         (2)  Indicates lower limit of analytical determination.’

      ANNEX III
      Part A of Annex II to Directive 90/642/EEC is amended as follows:

                  1.

                  The following column for fenthion is added:

                              Groups and examples of individual products to which the MRLs apply

                              Fenthion and its oxygen analogue, their sulfoxides and sulfones expressed as parent

                              ‘1.

                                 Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar; nuts

                              (i)

                              CITRUS FRUIT

                              3

                              Grapefruit

                              Lemons

                              Limes

                              Mandarins (including clementines and other hybrids)

                              Oranges

                              Pomelos

                              Others

                              (ii)

                              TREE NUTS (shelled or unshelled)

                              0,01 (1)

                              Almonds

                              Brazil nuts

                              Cashew nuts

                              Chestnuts

                              Coconuts

                              Hazelnuts

                              Macadamia

                              Pecans

                              Pine nuts

                              Pistachios

                              Walnuts

                              Others

                              (iii)

                              POME FRUIT

                              0,01 (1)

                              Apples

                              Pears

                              Quinces

                              Others

                              (iv)

                              STONE FRUIT

                              Apricots

                              Cherries

                              2

                              Peaches (including nectarines and similar hybrids)

                              Plums

                              Others

                              0,01 (1)

                              (v)

                              BERRIES AND SMALL FRUIT

                              0,01 (1)

                              (a)

                              Table and wine grapes

                              Table grapes

                              Wine grapes

                              (b)

                              Strawberries (other than wild)

                              (c)

                              Cane fruit (other than wild)

                              Blackberries

                              Dewberries

                              Loganberries

                              Raspberries

                              Others

                              (d)

                              Other small fruit and berries (other than wild)

                              Bilberries

                              Cranberries

                              Currants (red, black and white)

                              Gooseberries

                              Others

                              (e)

                              Wild berries and wild fruit

                              (vi)

                              MISCELLANEOUS

                              Avocados

                              Bananas

                              Dates

                              Figs

                              Kiwi

                              Kumquats

                              Litchis

                              Mangoes

                              olives (table consumption)

                              1

                              olives (oil extraction)

                              1

                              Papaya

                              Passion fruit

                              Pineapples

                              Others

                              0,01 (1)

                              2.

                                 Vegetables, fresh or uncooked, frozen or dry

                              0,01 (1)

                              (i)

                              ROOT AND TUBER VEGETABLES

                              Beetroot

                              Carrots

                              Cassava

                              Celeriac

                              Horseradish

                              Jerusalem artichokes

                              Parsnips

                              Parsley root

                              Radishes

                              Salsify

                              Sweet potatoes

                              Swedes

                              Turnips

                              Yam

                              Others

                              (ii)

                              BULB VEGETABLES

                              Garlic

                              Onions

                              Shallots

                              Spring onions

                              Others

                              (iii)

                              FRUITING VEGETABLES

                              (a)

                              Solanacea

                              Tomatoes

                              Peppers

                              Aubergines

                              Okra

                              Others

                              (b)

                              Cucurbits - edible peel

                              Cucumbers

                              Gherkins

                              Courgettes

                              Others

                              (c)

                              Cucurbits - inedible peel

                              Melons

                              Squashes

                              Watermelons

                              Others

                              (d)

                              Sweet corn

                              (iv)

                              BRASSICA VEGETABLES

                              (a)

                              Flowering brassica

                              Broccoli

                              Cauliflower

                              Others

                              (b)

                              Head brassica

                              Brussels sprouts

                              Head cabbage

                              Others

                              (c)

                              Leafy brassica

                              Chinese cabbage

                              Kale

                              Others

                              (d)

                              Kohlrabi

                              (v)

                              LEAF VEGETABLES AND FRESH HERBS

                              (a)

                              Lettuce & similar

                              Cress

                              Lamb's lettuce

                              Lettuce

                              Scarole

                              Ruccola

                              Leaves and stems of brassica

                              Others

                              (b)

                              Spinach & similar

                              Spinach

                              Beet leaves (chard)

                              Others

                              (c)

                              Water cress

                              (d)

                              Witloof

                              (e)

                              Herbs

                              Chervil

                              Chives

                              Parsley

                              Celery leaves

                              Others

                              (vi)

                              LEGUME VEGETABLES (fresh)

                              Beans (with pods)

                              Beans (without pods)

                              Peas (with pods)

                              Peas (without pods)

                              Others

                              (vii)

                              STEM VEGETABLES (fresh)

                              Asparagus

                              Cardoons

                              Celery

                              Fennel

                              Globe artichokes

                              Leek

                              Rhubarb

                              Others

                              (viii)

                              FUNGI

                              (a)

                              Cultivated mushrooms

                              (b)

                              Wild mushrooms

                              3.

                                 Pulses

                              0,01 (1)

                              Beans

                              Lentils

                              Peas

                              Others

                              4.

                                 Oil seed

                              0,02 (1)

                              Linseed

                              Peanuts

                              Poppy seeds

                              Sesame seeds

                              Sunflower seed

                              Rape seed

                              Soya bean

                              Mustard seed

                              Cotton seed

                              Hemp seed

                              Others

                              5.

                                 Potatoes

                              0,01 (1)

                              Early potatoes

                              Ware potatoes

                              6.

                                 Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia sinensis)

                              0,1 (1)

                              7.

                                 Hops (dried), including hop pellets and unconcentrated powder

                              0,1 (1)

                  2.

                  The columns for atrazine, azinphos-ethyl, cyfluthrin, ethephon, methamidophos, methomyl, paraquat and triazophos are replaced by the following:

                              Groups and examples of individual products to which the MRLs apply

                              Atrazine

                              Azinphos-ethyl

                              Cyfluthrin including other mixtures of constituent isomers (sum of isomers)

                              Ethephon

                              Methamidophos

                              Methomyl/Thiodicarb (sum expressed as methomyl)

                              Paraquat

                              Triazophos

                              ‘1.

                                 Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar; nuts

                              0,05 (2)

                              0,02 (2)

                              0,02 (2)

                              0,01 (2)

                              (i)

                              CITRUS FRUIT

                              0,02 (2)

                              0,05 (2)

                              0,01 (2)

                              Grapefruit

                              0,5

                              Lemons

                              1

                              Limes

                              1

                              Mandarins (including clementines and other hybrids)

                              1

                              Oranges

                              0,5

                              Pomelos

                              0,5

                              Others

                              0,05 (2)

                              (ii)

                              TREE NUTS (shelled or unshelled)

                              0,02 (2)

                              0,1

                              0,01 (2)

                              0,05 (2)

                              Almonds

                              Brazil nuts

                              Cashew nuts

                              Chestnuts

                              Coconuts

                              Hazelnuts

                              Macadamia

                              Pecans

                              Pine nuts

                              Pistachios

                              Walnuts

                              Others

                              (iii)

                              POME FRUIT

                              0,2

                              0,01 (2)

                              0,2

                              Apples

                              0,5

                              Pears

                              Quinces

                              Others

                              0,05 (2)

                              (iv)

                              STONE FRUIT

                              Apricots

                              0,3

                              0,1

                              0,2

                              Cherries

                              0,2

                              3

                              0,1

                              Peaches (including nectarines and similar hybrids)

                              0,3

                              0,05

                              0,2

                              Plums

                              0,2

                              0,5

                              Others

                              0,02 (2)

                              0,05 (2)

                              0,01 (2)

                              0,05 (2)

                              (v)

                              BERRIES AND SMALL FRUIT

                              0,01 (2)

                              (a)

                              Table and wine grapes

                              0,3

                              1

                              Table grapes

                              0,05 (2)

                              Wine grapes

                              1

                              (b)

                              Strawberries (other than wild)

                              0,02 (2)

                              0,05 (2)

                              0,05 (2)

                              (c)

                              Cane fruit (other than wild)

                              0,02 (2)

                              0,05 (2)

                              0,05 (2)

                              Blackberries

                              Dewberries

                              Loganberries

                              Raspberries

                              Others

                              (d)

                              Other small fruit and berries (other than wild)

                              0,02 (2)

                              0,05 (2)

                              Bilberries

                              Cranberries

                              Currants (red, black and white)

                              5

                              Gooseberries

                              Others

                              0,05 (2)

                              (e)

                              Wild berries and wild fruit

                              0,02 (2)

                              0,05 (2)

                              0,05 (2)

                              (vi)

                              MISCELLANEOUS

                              0,02 (2)

                              0,01 (2)

                              0,05 (2)

                              Avocados

                              Bananas

                              Dates

                              Figs

                              Kiwi

                              Kumquats

                              Litchis

                              Mangoes

                              olives (table consuption)

                              olives (oil extraction)

                              Papaya

                              Passion fruit

                              Pineapples

                              2

                              Others

                              0,05 (2)

                              2.

                                 Vegetables, fresh or uncooked, frozen or dry

                              0,02 (2)

                              0,02 (2)

                              0,01 (2)

                              (i)

                              ROOT AND TUBER VEGETABLES

                              0,05 (2)

                              0,02 (2)

                              0,05 (2)

                              0,01 (2)

                              Beetroot

                              Carrots

                              Cassava

                              Celeriac

                              Horseradish

                              Jerusalem artichokes

                              Parsnips

                              Parsley root

                              Radishes

                              0,5

                              Salsify

                              Sweet potatoes

                              Swedes

                              Turnips

                              Yam

                              Others

                              0,05 (2)

                              (ii)

                              BULB VEGETABLES

                              0,05 (2)

                              0,02 (2)

                              0,05 (2)

                              0,01 (2)

                              0,05 (2)

                              Garlic

                              Onions

                              Shallots

                              Spring onions

                              Others

                              (iii)

                              FRUITING VEGETABLES

                              0,01 (2)

                              (a)

                              Solanacea

                              0,05 (2)

                              Tomatoes

                              0,05

                              1

                              0,2

                              Peppers

                              0,3

                              3

                              Aubergines

                              0,2

                              Okra

                              Others

                              0,02 (2)

                              0,05 (2)

                              0,05 (2)

                              (b)

                              Cucurbits - edible peel

                              0,05 (2)

                              0,05 (2)

                              0,05 (2)

                              Cucumbers

                              0,1

                              Gherkins

                              Courgettes

                              Others

                              0,02 (2)

                              (c)

                              Cucurbits - inedible peel

                              0,05 (2)

                              0,02 (2)

                              0,05 (2)

                              0,05 (2)

                              Melons

                              Squashes

                              Watermelons

                              Others

                              (d)

                              Sweet corn

                              0,1

                              0,02 (2)

                              0,05 (2)

                              0,05 (2)

                              (iv)

                              BRASSICA VEGETABLES

                              0,05 (2)

                              0,05 (2)

                              (a)

                              Flowering brassica

                              0,05

                              0,02

                              Broccoli

                              0,2

                              Cauliflower

                              Others

                              0,05 (2)

                              (b)

                              Head brassica

                              0,2

                              0,01 (2)

                              0,05 (2)

                              Brussels sprouts

                              Head cabbage

                              Others

                              (c)

                              Leafy brassica

                              0,3

                              0,01 (2)

                              0,05 (2)

                              Chinese cabbage

                              Kale

                              Others

                              (d)

                              Kohlrabi

                              0,02 (2)

                              0,01 (2)

                              0,05 (2)

                              (v)

                              LEAF VEGETABLES AND FRESH HERBS

                              0,05 (2)

                              0,05 (2)

                              0,01 (2)

                              (a)

                              Lettuce & similar

                              0,5

                              Cress

                              Lamb's lettuce

                              Lettuce

                              0,3

                              Scarole

                              Ruccola

                              Leaves and stems of brassica

                              Others

                              0,05 (2)

                              (b)

                              Spinach & similar

                              0,02 (2)

                              Spinach

                              0,05

                              Beet leaves (chard)

                              Others

                              0,05 (2)

                              (c)

                              Water cress

                              0,02 (2)

                              0,05 (2)

                              (d)

                              Witloof

                              0,02 (2)

                              0,05 (2)

                              (e)

                              Herbs

                              0,02 (2)

                              0,3

                              Chervil

                              Chives

                              Parsley

                              Celery leaves

                              Others

                              (vi)

                              LEGUME VEGETABLES (fresh)

                              0,05 (2)

                              0,05

                              0,05 (2)

                              0,05 (2)

                              Beans (with pods)

                              0,5

                              Beans (without pods)

                              Peas (with pods)

                              0,5

                              Peas (without pods)

                              Others

                              0,01 (2)

                              (vii)

                              STEM VEGETABLES (fresh)

                              0,05 (2)

                              0,02 (2)

                              0,05 (2)

                              0,05 (2)

                              Asparagus

                              Cardoons

                              Celery

                              Fennel

                              Globe artichokes

                              0,1

                              Leek

                              Rhubarb

                              Others

                              0,01 (2)

                              (viii)

                              FUNGI

                              0,05 (2)

                              0,02 (2)

                              0,05 (2)

                              0,01 (2)

                              0,05 (2)

                              (a)

                              Cultivated mushrooms

                              (b)

                              Wild mushrooms

                              3.

                                 Pulses

                              0,05 (2)

                              0,02 (2)

                              0,02 (2)

                              0,05 (2)

                              0,01 (2)

                              0,05 (2)

                              0,02 (2)

                              0,01 (2)

                              Beans

                              Lentils

                              Peas

                              Others

                              4.

                                 Oil seed

                              0,05 (2)

                              0,02 (2)

                              0,02 (2)

                              0,01 (2)

                              Linseed

                              Peanuts

                              0,1

                              Poppy seeds

                              Sesame seeds

                              Sunflower seed

                              Rape seed

                              0,05

                              Soya bean

                              0,2

                              0,1

                              Mustard seed

                              Cotton seed

                              2

                              0,2

                              0,1

                              Hemp seed

                              Others

                              0,02 (2)

                              0,1 (2)

                              0,01 (2)

                              0,05 (2)

                              5.

                                 Potatoes

                              0,05 (2)

                              0,02 (2)

                              0,02 (2)

                              0,05 (2)

                              0,01 (2)

                              0,05 (2)

                              0,02 (2)

                              0,01 (2)

                              Early potatoes

                              Ware potatoes

                              6.

                                 Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia sinensis)

                              0,1 (2)

                              0,05 (2)

                              0,1 (2)

                              0,1 (2)

                              0,02 (2)

                              0,1 (2)

                              0,05 (2)

                              0,02 (2)

                              7.

                                 Hops (dried), including hop pellets and unconcentrated powder

                              0,1 (2)

                              0,05 (2)

                              20

                              0,1 (2)

                              0,02 (2)

                              10

                              0,05 (2)

                              0,02 (2)

         (1)  Indicates lower limit of analytical determination.’

         (2)  Indicates lower limit of analytical determination.’