4 replies to this topic

[Lane]

Hello all,
I'm new to the forums and new to the food industry, so please bear with me if my ignorance (of either or both) shows.

I work for a tea company and we are working on establishing company requirements regarding heavy metals in our ingredients. When I refer to heavy metals I'm talking specifically about: Arsenic, Cadmium, Mercury, Chromium, & Lead. I want to make sure the requirements we develop are based on relevant regulatory standards and I could use some help being pointed in the right direction.

I've looked to FDA standards, but - if I understand correctly - there does not exist "blanket" FDA standards for concentration limits of heavy metals in food. I know that there are limits on lead in candy and various metals in fish as well as EPA standards for heavy metals in drinking water. Now, let me further the story a bit, my company sells products internationally as well as within the US; so I might be looking to the wrong regulatory agency in the first place. We sell products to Canada, Mexico, the EU, Australia, and Japan. What I'd like to do is find the most "strict" regulatory requirements of these countries to use as our standard.

Any help or comments you can provide will be greatly appreciated.

Regards,
Lane

[Happyme]

You may want to consider following links.

• http://www.lef.org/p...prtcl-156.shtml
• http://www.ema.europ...WC500003587.pdf
• http://www.foodquali...oodstuffs_.html

Hope it helps.

[Simon]

European Union: For the heavy metals cadmium, lead and mercury, maximum levels in certain foods have been established by Commission Regulation (EC) No 1881/2006.

Members from other regions please share your regulations.

Regards,
Simon

[Miriam M.]

RECOMMENDATION: Set up a maximum usagerate dependent on the most limited HM in the ingredient if the ingredient has no established heavy metal (HM) standard. I attach a great article from Herbal Products Asso on HM recommended limits for botanicals as a starting point.

Under Section 402(a)(1) of the FD&C Act(21 U.S.C. 342(a)(1)), a food is deemed adulterated if the food bears orcontains any added poisonous or deleterious substance which may render the foodinjurious to health, and for substances that are not added substances, if thequantity of the substance ordinarily renders the food injurious to health. Assuch, in the event we find a contaminant in a food that poses a health hazard,such that the food is deemed to be adulterated, FDA may lawfully takeappropriate enforcement action.

Aside from thelimited examples identified in below references, FDA has not addressed the issue of heavymetals in foods, and has not instituted any regulation or provided contemporaryrecommendations for heavy metal tolerances for conventional foods generally.

The U.S. Food andDrug Administration (FDA) enforces action levels for poisonous or deleterioussubstances in human food and animal feed, including cadmium, lead, mercury, andothers (ref. 1) The FDA has also developed a comprehensive Food Protection Planto address the challenges and changes occurring in food sources, production,and consumption. (ref. 2). The plan builds upon advances in science andtechnology to protect the nation’s food supply from both unintentionalcontamination and deliberate attack.

The EuropeanCommission directive 1881/2006 (ref 3) specifies maximum levels for Cd,inorganic Sn, Hg, and Pb in a variety of foodstuffs (but not juice-derivedcolourants or food preparations), with, for example, 0.02 mg Pb/kgallowable in milk products and up to 1.5 mg Pb/kg allowable in bivalvemollusks.

References:

• U.S. Food and Drug Administration. Guidance for Industry: Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed. Available at: www.fda.gov/Food/ GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ChemicalContaminantsandPesticides/ucm077969.htm. Accessed January 21, 2010.
• U.S. Food and Drug Administration. Fact Sheet: Food Protection Plan. Available at: www.fda.gov/Food/FoodSafety/FoodSafetyPrograms/FoodProtectionPlan2007/ucm132705.htm. Accessed January 21, 2010.
• European Commission. Commission Regulation (EC) N  09_0113_AHPA_Heavy_Metal_White_Paper_Final_20090101.pdf   342.43KB   53 downloadso 1881/2006 of 19 December 2006
  setting maximum levels for certain contaminants in foodstuffs. Available
  at: eurlex.europa.eu/LexUriServ/site/en/oj/2006/l_364/l_36420061220en00050024.pdf. Accessed January 21, 2010.
• European Commission. Commission Regulation (EC) No 629/2008 of 2 July 2008 amending Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs. Available at: www.fsai.ie/uploadedFiles/Commission_Regulation_EC_No_629_2008.pdf. Accessed January 21, 2010.

[Charles.C]

Dear Lane,

As you hv probably realised, "most strict" encompasses a variety of interpretations. logically any standard should hv a validatable scientific basis, eg involving things like prevalence / consumption habits. Sampling / analytical procedures can also be relevant.

In the (worst?) case scenario, lack of knowledege or intentions for "ultimate' strictness result in a detection limit criterion (philosophically analogous to the micro. zero tolerance).

In practice, most (all?) countries also have an internal sovereign right to select/deselect/modify general requirements to produce their own specific criteria. The exact flexibility may depend on the parameter / status of a "regulation".

You are going to generate an interesting compilation. My guess is that some wide-ranging databases do exist in addition to the useful but mostly localised refs in previous posts. IMEX, i ended up with a (very) large file of every customer country of relevance. And similarly for micro. standards etc. I am guessing that 4/5 of yr posted list will be relatively determinable. EU IMEX (not for tea products) may well be a different proposition. Good luck.

Rgds / Charles.C