STEPS NEEDED TO ACHIEVE EU ACCREDITATION
FOR HONEY EXPORT
Gudrun Beckh, Quality Services International GmbH (QSI), Germany

Education/Support

Quality Management / Quality Control of Bee Products

• HACCP (Hazard Analysis Critical Control Point)
• ISO 9000 ff
• Carry out the appropriate external audits
• Consulting of companies
• Licensed institute according to EN 17025

Organic Production (Natural Food / Natural Commodities)
for trading with products from organic production special care must be taken.

• Give assistance/support in fulfilling the legal regulations and duties
• Act as authorised private inspection body according to the regulation(EC) No 2092/91 and 1804/99.

Quality Management / Quality Control of Bee Products

Means:

• analysing honey types from all over the world on origin and qualitymain subjects are: - control of residues (anti-Varroa chemicals, antibiotics, pesticides) - HMF, moisture, diastase, pollen, sugars, acid degree, proline, pH-value - sensory (taste, odour, appearance)
• analysing bee products like royal jelly, pollen, propolis or beeswax
  delivery of information and analysis of contents, adulteration and residues
• give consultancy for all honey importers and packers in Europe concerning quality control of their products.

European Community

Bees produce honey from plant sources > HONEY = ANIMAL PRODUCT

The European Commission is more and more focusing on the Quality Control of foodstuffs especially of animal origin.

Through this:

• The regulation concerning the quality control of honey have strongly increased.
• The honey market is concerned by an increasing number of residue problems.
• The honey trade is influenced by negative incidents caused by residues of not permitted substances in animal foode.g.in the case of Chloramphenicol (CAP) this has led to a complete ban of imports from China (2002-2004).

European Community Legislation

• Council Regulations law in every member state
• EC Directives shall be adopted in member states no legal force until promulgated by national parliament
• Horizontal legislation refers to all food stuffs  e.g. for contaminants, additives, labelling
  Regulation EEC 2377/90 (maximum  residues limits for veterinary drugs)  Directive 96/23/EC (monitoring)
• Vertical legislation refers to specific products  e.g. Honey Directive 2001/110/EC Directive 2002/337/EC (list of third  countries allowed to import honey from)

Commission Decision 2006/208/ECof 7 March 2006

...amending Decision 2004/432/EC on the approval of residue monitoring plans submitted by third countries in accordance with Council Directive 96/23/EC.

These third countries submitted a residue monitoring plan according to honey:

EU import of animal products from third countries

Guidance to the national authorities in third countries:

• General principles
• Animal health situation
• Residues, contaminants and additives controls
• Food safety standards in processing establishments
• National authority standards
• Country approval procedure (Uganda already approved)
• Health certification
• Border inspection upon entry to the EU
• Initial contact point
• Health and Consumer protection Directorate-General (DG Sanco)
  http://ec.europa.eu/dgs/health_consumer/index_en.htm

General principles: Particular account is taken of e.g.:

• Health status of livestock/diseases
• Legislation of the country on live animals and products of animal origin
• Organisation of competent veterinary authority
• Training of staff in the performance of official controls
• Existence and operation of documented control procedures
• Hygiene conditions
• Use of veterinary medicinal products/legislation
• Residue control programme
• EU import of animal products from third countries

Animal health situation

• Third country must be member of OIE (world organisation for animal health)
• Laboratory facilities for detection and confirmation of diseases (major serious outbreaks have to be communicated within 24 h after confirmation)
• Animal disease control systems must be in place

Residues, contaminants and additives controls

• Legal controls over prohibited substances
• Monitoring programme for these substances

Monitoring System

Basis for the import to the European Union

Council Directive 96/23/ECof 29 April 1996
on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/496/EEC and Decisions 89/187/EEC and 91/664/EEC

The Directive lays down:

• Guidelines for the residue control in animals and in their products
• Detailed procedures to set up a National monitoring plan
• Details on sampling procedures
• The set of substances and groups of residues that must be monitored (Annex I).

Annex I to Directive 96/23/EC

GROUP A – Substances having anabolic effect and unauthorized substances

• Stilbenes, Stilbene derivates, and their salts and esters
• Anti-thyroid agents
• Steroids
• Resorcylic acid lactones including Zeranol
• Beta-agonists
• Compounds included in Annex IV to Council Regulation (EEC) No 2377/90 of 26 June 1990 e.g. Chloramphenicol (CAP)

GROUP B – Veterinary drugs (1) and contaminants (see also (EEC) No 2377/90)

Antibacterial substances, including sulphonamides, quinolones

Other veterinary drugs

Anthelminitics
Anticoccididials, including Nitroimidazoles
Carbamates and Pyrethroids
Sedatives
Non-steroidal anti-inflammatory drugs (NSAIDs)
Other pharmacologically actives substances

Other substances and environmental contaminants

Organochlorine compounds including PCBs
Organophosphorus compounds
Chemical elements, e.g. heavy metals
Mycotoxins
Dyes
Others

Including unlicensed substances which could be used for veterinary purposes

Veterinary drugs and contaminants are controlled in:

Honey

Substances or group of substances to be monitored mandatory:

• Group A 6: Compounds included in Annex IV to Council Regulation 2377/90/EEC
  - Chloramphenicol, Nitrofurans
• Group B 1: Antibacterial substances
  - Streptomycin, Sulphonamides, Tetracyclins, Tylosin

Other groups of substances that should be monitored:

Carbamates and pyrethroids (B 2c), organochlorine compounds incl. PcBs (B 3a), organophosphorous compounds (B 3b), chemical elements (B 3c)

Sampling frequency

Number of samples/year analysed by government laboratories or laboratories acting for the government under contract:

• 10 per 300 tons of annual production for the first 3000 tons
• 1 sample for each additional 300 tons

Breakdown for single groups:

• B 1 and B 2c: 50% of the total number of samples
• B 3a, b, and c: 40% of the total number of samples

FVO (Food of Veterinary Office)

The Commision is responsible for ensuring that Community legislation on food safety, animal health, plant health and animal welfare is properly implemented and enforced. Therefore they conduct inspections on spot:

• in member states on special topics e.g. Germany/BSE control
• in EU candidate countries to assess countries readiness e.g. Bulgaria/Residues
• in third countries to ensure that competent authorities correctly apply relevant EU standards e.g. South Africa/Pesticides

FVO inspection: Brazil

• Unsufficient quality control analysis
• Procedures have to be harmonized with EU ones
• National residue control plan is unsufficient and not implemented, official labs not capable of testing adequately
• Free availability of most veterinary drugs and absence of requirements on documentation of use
• Export of honey in absence of any testing
• Since 17-March-2006 embargo against Brazilian honey
• Six months deadline to restructuring national programme in order to adapt to the EU export norms

FVO - You can find FVOs

• Inspection programmes
• Inspection reports
• Annual reports
• Special reports

under: http://ec.europa.eu/food/fvo/index_en.htm

EU import of animal products from third countries

Food safety standards in processing establishments

• HACCP principles
• Effective official control system, incl. documented records of control actions
• Independence of operators/supervisory systems
• Estalishments must meet EU standard

HACCP

HACCP (Hazard Analysis and Critical Control Point) is a tool of the hygiene management

The HACCP principles (laid down in Annex II Hygiene Regulation 852/2004) have to be adopted by companies which produce, deal, pack, store and export honey.

The appliance is no voluntary act but required by law and has to be confirmed by the companies.

EU import of animal products from third countries

National authority standards

• National authority must be able to deliver the level of veterinary controls required
• Questionnaire to national authority e.g. management structure, independence, resources, personnel, recruitment and training, legal/enforcement of powers, priorisation and documentation of controls, laboratory services, import controls, animal health controls, food safety controls

Health certification

• Imports of animal products into EU must be accompanied by the health certification laid down in EU legislation
• Strict rules on producton, signing and issuing of certificates
• Original version of certificate must accompany consignments
• Each category of animal and product has ist own set of requirements

Border inspection upon entry to the EU

• Products must enter via an approved Border Inspection Post (BIP), located in a member state of EU
• Animal or product must be subject to official veterinary checks in border inspection

Initial contact point

Directorate D, Health and Consumer protection Directorate-General, European Commission, Rue Froissart 101, B-1049 Brussels
Tel: +32 2 2953641
Fax: +32 2 2964286

http://ec.europa.eu/food/index_en.htm

EC Directives and Regulations concerning Honey

• Monitoring Programme Council Directive 96/23/EC
• Honey Directive 2001/110/EC
• Regulation 2377/90 regarding residues of pharmaceutical active substances
• Food Safety Regulation 178/02
• Pesticide Regulation 396/05
• Hygiene Regulations 852-854/04

website: http://www.eur-lex.europa.eu/

 

EC Honey Directive

Council Directive 2001/110/ECof 20. December 2001 relating to honey lays down the definition and composition of honey

Art.1 Where the Directive shall apply to (Annex I)
Which requirements the products shall meet (Annex II)

Annex I

1. Definition

Honey is the natural sweet substance produced by Apis mellifera bees from the nectar of plants or from secretions of living parts of plants or excretions of plant- sucking insects on the living parts of plants, which the bees collect, transform by combining with specific
substances of their own, deposit, dehydrate, store and leave in honeycombs to ripen and mature.

2. The main types of honey are as follows:

a) According to origin

i) Blossom honey or nectar honey

ii) Honeydew honey

According to mode of production and/or presentation

i) Comb honey

ii) Chunk honey or cut comb honey

iii) Drained honey

iv) Extracted honey

v) Pressed honey

vi) Filtered honey (new) - honey obtained by removing foreign inorganic or organic matter in such a way as to result in the significant removal of pollen.

3. Baker's honey

Honey which is

a) suitable for industrial uses or as an ingredient in other foodstuff which are then processed and

b) may:

Have a foreign taste or odour, or

Have begun to ferment or have fermented, or

Have been overheated.

Annex II

Composition Criteria of Honey

• Honey consists essentially of different sugars, predominantly fructose and glucose as well as other substances such as organic acids, enzymes and solid particles derived from honey collection.
• The colour of honey varies from nearly colourless to dark brown.
• The consistency can be fluid, viscous or partly to entirely crystallised.
• The flavour and aroma vary, but are derived from the plant origin.
• Honey shall not have added to it any food ingredient, including food additives, nor shall any other additions be made other than honey.
• Honey must, as far as possible (except baker’s honey),

  - be free from organic or inorganic matters foreign to its composition

  - not have any foreign taste or odour

  - not have begun to ferment

  - not have an artificially changed acidity or

  - not have been heated in such a way that the natural enzymes have
    been either destroyed or significantly inactivated.

• No pollen or constituents particular to honey may be removed except where this is unavoidable in the removal of foreign inorganic or organic matter (except filtered honey).

 

Declaration of Honey

Except in case of filtered honey and baker’s honey the product names may be supplemented by information referring to:

• floral or vegetable origin if the product comes wholly or mainly from the indicated source and possess the organoleptic, physico-chemical and microscopic characteristics of the source
• regional, territorial or topographical origin if the products comes entirely from the indicated source

Geographical origin of Honey

New:

• country or countries of origin shall be indicated on the label (Article 2, 4)
• for blends: every country listed or
• blend of EC-honeys
• blend of non-EC honeys
• blend of EC and non-EC-honeys

 

Difficulties for control:

'Detection limit' for finding all origins in blends of honey as the percentage is not defined.

Food safety

Regulation (EC) 178/2002of 28 January 2002

laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.

Main points are:

• The regulations provides the basis for the assurance of a high level of protection of human health and well-being of citizens, and to their social and economic interests.
• Considers necessary all aspects of the food production chain as a continuum from and including the production of animal feed in order to ensure safety of food.
• For ensuring continuous monitoring networking of laboratories of excellence, at regional and/or interregional level play an important role.

Food Safety

§14 Food safety requirements

Food shall be deemed to be unsafe if it is considered to be:

- injurious to health

- unfit for human consumption

In determining whether any food is unsafe, regard should be had:

- the normal conditions of use

- information provided to the consumer concerning the avoidance
  of specific adverse health effects

In determing whether any food is injurious to health, regard shall be had:

- the probable effects of that food on the health of a person
  consuming

- probable cumulative effects

- particular health sensitivities of a specific category of consumers

Risk Communication

§ 19 Responsibility for food

If a food is considered as not to be in compliance with the food safety requirements the operator shall:

- initiate procedures to withdraw the food in question from the
  market where the food has left immediate control

- inform the competent authorities

- inform the consumers of the reasons for its withdrawal and if
  necessary recall  products already supplied from the consumers

Residues

Regulation (EEC) No 2377/90 on veterinary medical products in foodstuff of animal origin

lays down what substances are forbidden

Regulation (EEC) No 2377/90 of 26 June 1990 on veterinary medicinal products in foodstuff of animal origin

• The regulation binds the maximum residue limits (MRL) for veterinary medicinal products in foodstuffs of animal origins.
• Limits are established in accordance with the regulatory committee procedure following scientific evaluation by the Committee for Veterinary Medical Products (CVMP) of the European Medicines Evaluation Agency (EMEA).
• The pharmacologically active substances are classified in 4 Annexes to the Regulation.

Positive Lists!!
The lists will be continually updated

EU: allowed veterinary drugs

According to Regulation 2377/90 Annex I (with MRL)

Coumafos MRL 0,1mg/kg
Amitraz MRL 0,2 mg/kg

According to Regulation 2377/90 Annex II (no MRL)
Lactic acid (for all food producing species)
Phenol (for all food producing species)
Oxalic acid (only for bees)
Tau-Fluvalinat
Thymol

No other veterinary drugs are allowed to be used.

Pesticides

Pesticide Residues

• Pesticide Regulation 396/05/EC for all foodstuffs incl. honey
• existing national MRLs can still be applied as long as Annex III with new harmonised MRLs will be in force
• if no specific MRL is set a 'standard MRL' of 0,01 mg/kg shall be applied
• Honey as regarded as natural and pure should be as free from residues as possible.
• Industry may/will include requirements in their contracts
  e.g. specifying compliance with the residue limits stipulated in the European Pharmacopoeia.
  Hygiene

Hygiene

EC Hygiene Regulations

• 852/2004 general food hygiene
• 853/2004 specific requirements for food of animal origin
• 854/2004, specific procedures for the official control of food of animal origin

replacing 16 different Directives

What is new?

• primary production is included
• all food producing companies must be registered
• principle of equivalence for imported food from third countries
• HACCP mandatory as well as documentation and self-control except for primary production
• Flexibility for small businesses

Influence on Monitoring Food Quality

International Recommendations e.g. Codex Alimentarius

European Community: EC-Regulations, EC Directives

National Law: German Food Regulation (LMBG) and related Directives  e.g. German Honey Directive, Pesticide Directive

Specifications of the Importers

Specifications of the Packers

Trade specifications of Supermarkets

Consumer resp. Consumer journals

Associations e.g. German Beekeeping Association

Exporters resp. factories

Beekeeper

Why is it necessary to define Quality of Honey?

Today major factor for quality of honey

• Incorrect apiculture practice
• including hygiene e.g. as prevention of diseases instead of using 'medicine'
  

 

Contaminants in honey

	Environment - Pesticides - Heavy metals - Bacteria   Genetically modified   organisms (GMO) - Radioactivity	Beekeeping - Acridicides for Varroa control - Antibiotics against diseases e.g.   AFB, EFB - Pesticides for wax moth control - Repellents at honey harvest - Other contaminants
	Plants, Air, Water

• Responsible for official procedures: national authorities
  
  
• Bee-keepers have influence on the quality of the product by implementing quality standards and correct treatment
  

What can we do to improve on honey quality?

Voluntary action to improve honey quality

Producers should at least use as preventive measures

• GBP (Good Beekeeping Practises)
• GHP (Good Hygiene Practises)

The producers, packers and processors should establish a

• Quality Management System (Quality Control, Quality Assurance)

Contaminants from bee-keeping and control measures

Control leads to confidence

  Download Gudrun Beckh's PowerPoint presentation here (576kb .pps file)