The European Food Safety Authority EFSA: Dealing with the safety of food enzymes

1
The European Food Safety Authority
(EFSA)Dealing with the safety of food enzymes

• Dr. HERMAN B.W.M. KOËTER Deputy Executive
  Director
• and
• Director of Science

2
EFSAs Mission and Tasks (Reg 178/2002)

• provide scientific advice and scientific and
  technical supportArt.22.2
• shall provide scientific opinions Art.22.6
• collect and analyse data to allow the
  characterisation and monitoring of
  risksArt.22.4
• promote and coordinate the development of
  uniform risk assessment methodologiesArt.23(b)
• commission scientific studiesArt.23(d)
• undertake action to identify emerging
  risksArt.23(f)

3
Scientific activities (work themes)

• Providing scientific opinions, guidance and
  advice in response to questions
• Assessing the risk of regulated substances and
  development of proposals for risk-related
  factors
• Monitoring of specific risk factors and diseases
• Development, promotion and application of new and
  harmonized scientific approaches and
  methodologies for hazard and risk assessment of
  food and feed.

4
The Eight Scientific Panels

• Food additives, flavourings, processing aids,
  materials in contact with food (AFC)
• Additives and products in animal feed (FEEDAP)
• Plant health plant protection products (PPR)
• Genetically modified organisms (GMO)
• Dietetic products, nutrition and allergies (NDA)
• Biological hazards (BIOHAZ)
• Contaminants in the food chain (CONTAM)
• Animal health and welfare (AHAW)

5
Assessing the risk of specific groups of chemical
substances

• Chemical categories include
• Food additives, flavourings, supplements,
  enzymes, processing aids.
• Food contact materials
• Additives for use in animal nutrition
• Pesticide ingredients
• Genetically modified food and feed.
• Risk related factors include MRLs

6
Assessing the risk of food enzymes

• Enzymes are currently only regulated as food
  additives (Invertase, Lysozyme)
• Consequently, when used as processing aids,
  enzymes are not regulated at EU level
• Opinion of the SCF of April 1991 recommended to
  focus on the safety, not how the enzymes are used
  (additive or processing aid)
• Today only a few MSs have national regulations,
  either mandatory (Denmark, France) or voluntary
  (UK)

7
Assessing the risk of food enzymes

• Current draft EU Regulation of June 2005 is based
  on the principle of the level of exposure as
  determining factor for test requirements and
  safety assessment
• Exposure may well include impurities
  (tryptophan!)
• Issues open for debate
• Generic or product-specific approval
• Produced from or with GMO/GMMs
• Content of the technical dossier.

8
Likely role of EFSA

• EFSA supports the regulation of food enzymes,
  including a prior authorisation procedure based
  on risk assessment by EFSA
• EFSA will develop a detailed Guidance Document
  for the preparation and presentation of
  applications, before the Regulation will come
  into force
• EFSA will arrange for a public consultation of
  the draft Guidance Document before its adoption

9
Likely role of EFSA

• EFSA will first assess the validity of
  applications (for inclusion in first phase
  list
• EFSA will carry out full risk assessments of all
  applications for inclusion in final list of
  approved enzymes.