Safety Assessment and Authorisation of Food Additives. Dr Iona Pratt Food Safety Authority of Ireland

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1 Safety Assessment and Authorisation of Food Additives Dr Iona Pratt Food Safety Authority of Ireland

2 NEWS Magazinee The day I ate as many E numbers as possible

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4 Additives must be safe before they are authorised for use in food! Talk will cover: What is an authorised food additive? Who does the authorisation and what does the process involve? How is their safety assessed?

5 Safety and regulation of food additives in the EC- basic principles Additives must be tested and shown to be safe before being allowed in food (by law) Specific tests laid out in published guidelines Test results assessed by committees of independent scientists Purity of additives controlled by legislation Uses of additives in food controlled by legislation

6 What is an authorised food additive? A food additive that is included in the positive list in Annex II of Regulation 1333/2008 Identified in list by name and E-number e.g. Ascorbic Acid, E300 Identified on the label of a foodstuff by their category and name or E-number e.g. Antioxidant, E300

7 Who does the authorisation? (placing an additive on the positive list) European Commission proposal voted on by Committee of Member State representatives (SCOFAH) Scrutiny procedure by European Parliament (3 months) EC regulation published in the Official Journal Additive now authorised and can be used

8 The end of the process! What comes before?

9 What does the process involve? 1. Application by industry to EC to include a new additive in the list or change conditions applying to an already approved additive Commission Guidelines on how to make an application 2. Commission request European Food Safety Authority (EFSA) to evaluate the safety of the additive

10 What does the process involve (2)? 3. EFSA opinion on safety (published) 4. Safety, conditions of use and maximum permitted levels in food discussed in Working Group on Additives (governmental experts on food additives) 5. Agreement on these

11 What does the process involve (3)? 6. Commission makes a proposal to include additive in the positive list Usually contains proposal for a number of additives Vote Drawn-out process EFSA now have 9 months to give an opinion, another 9 months for Commission to make proposal, 3 months for scrutiny procedure

12 Ireland s involvement in the process Participate in the meetings of national experts and voting forum Ensure Irish industry is aware of changes that may affect them/argue for preferred Irish position e.g. use of nitrites/nitrates in cured meats nitrates in lettuce/spinach etc Where does Bacon get its characteristic colour from? Curing salts use of aluminium-containing food additives in fine bakery ware

13 Ireland s involvement in the process Bring forward issues at the request of Irish industry e.g use of propylene glycol in Irish cream liqueurs at a level higher than previously permitted Make proposals for new additions (for evaluation by EFSA) Ireland/Irish industry not normally involved in making proposals for new additions to list of permitted additives, as industry is small in Ireland

14 Additives must be safe before they are authorised for use in food! Talk will cover: What is an authorised food additive? Who does the authorisation and what does the process involve? How is their safety assessed?

15 Assessing the safety of food additives Dossier assessed by EFSA ANS Committee of independent scientists with expertise in toxicology, food chemistry and exposure assessment Scientific Committee on Food (SCF) previously carried out this assessment (up to 2003)

16 Assessing the safety of food additives Information on chemistry of additives, specifications, intended use Toxicological studies in animals covering toxicity, genotoxicity, carcinogenicity, effects on reproduction, other effects Information in humans if available

17 EFSA normally establishes an ADI for the additive "an estimate of the amount of food additive, expressed on a body weight basis, that can be ingested daily over a lifetime without appreciable health risk. Established by applying a safety factor (uncertainty factor) to the concentration of the additive found in the toxicological studies found to produce no health effects in the animals NOAEL/UF = ADI

18 Assessing the safety of food additives Estimations of likely exposure of humans if additive is used as indicated by industry (categories of food, likely use levels) If ADI is higher than estimated exposure, EFSA concludes additive is likely to be safe if used as indicated If ADI is lower than estimated exposure, EFSA concludes that there is concern about safety Can be other reasons why EFSA concludes there is concern about safety, e.g. the additive is thought to be carcinogenic

19 Assessing the safety of food additives EFSA assesses safety of new additives, but is also in the process of assessing the already authorised additives e.g. food colours Additives where there is new information casting doubts on safety e.g. aspartame

20 CONCLUSIONS Food additives go through an extensive period of safety assessment and review before they are authorised for use in food in Europe A number of bodies involved in assessment (EFSA, European Commission, national experts, European Parliament) = multiple checks

21 CONCLUSIONS Many benefits associated with use of food additives, e.g. Preservatives, Antioxidants Emulsifiers (can reduce amount of fat used in a food), etc If you take out all the fat, what do you put in instead??? E-numbers in food are not a bad sign Additives are considered to be safe before they are authorised for use in food!

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23 Thank you! Any questions?