IPPA (the International Pectin producers’ Association) is a global association of the principal companies that manufacture pectin. To address possible uncertainty regarding Proposition 65 on methanol and food products containing pectin IPPA has issued the following advisory letter:
On 16th March 2012, last updated on 29th December 2023, CA OEHHA (California Office of Environmental Health Hazard Assessment) under the CA EPA (Environmental Protection Agency) announced that methanol would be added to the Proposition 65 list of substances known to the state of California to cause reproductive toxicity. The proposed safe harbor number, i.e. the maximum allowable dose level (MADL) is 23,000 micrograms per day. This would require businesses that knowingly expose the California public to levels of methanol above 23,000 micrograms per day to post a warning.
CA OEHHA released Interpretive Guideline No. 2012-01 regarding methanol in fruits and vegetables. This guideline states that “exposure to methanol in foods prepared from fruits and vegetables does not constitute an exposure within the meaning of Proposition 65 when the methanol results from pectin that occurs naturally in fruits and vegetables.”[i]
IPPA (International Pectin Producers Association) has been in dialogue with OEHHA to clarify the implications regarding added pectin (INS 440) in relation to the proposed Proposition 65 on Methanol. Under this dialogue, OEHHA has confirmed that the Proposition 65 regulation deals with environmental and occupational health hazards and does not deal with food safety or question the food safety of the use of added pectin in food applications.
IPPA has concluded as follows:
- The proposed Proposition 65 listing of methanol does not raise doubts about the safety of added pectin in food.
- OEHHA officials have explained that their intent is to regulate methanol exposure, not pectin or to question its safety as already reviewed by the US FDA.
- The US FDA has determined that pectin is GRAS (Generally Recognized As Safe) for general use in foods up to GMP levels (21 CFR 184.1588).
- On a global scale, the WHO JECFA/FAO have deemed pectins as safe food additives (71st JECFA, 2009) with a group ADI “not specified”[ii] (25th JECFA, 1981).
- Within the meaning of Proposition 65, handling and use of commercial pectin during manufacturing, transportation and final food processing does not constitute any exposure of workers, consumers or the environment to methanol.
- Commercial pectin is a purified aqueous extract of pectin naturally occurring in fruits and vegetables. After the purification, drying and milling processes no methanol – or only insignificant traces of methanol – is left in the commercial pectin product.
- Methanol is not used in the production process (purification) of commercial pectin by any IPPA member.
- In order to ensure the desired functionality of added pectin a specific and constant methyl ester content in the pectin is required. GMPs accordingly involve measures to ensure that no de-esterification takes place during production and throughout the shelf life of the foodstuff. (Possible methyl-esterase activity must, for example, be terminated before or shortly after the addition of commercial pectin).
- Within the meaning of Proposition 65, consumption of food containing pectin does not constitute any exposure to methanol originating from added pectin.
- IPPA determination of methanol content of commercial pectins typically falls in the range 50 – 600 ppm. Accordingly, methanol exposure from added pectin in a normal diet only constitutes a small fraction of the proposed MADL threshold of 23000 micrograms/day. (Estimating an average methanol content of 300 ppm in commercial pectin and a use level in food typically ranging from 0,05- to 0,5% one should consume from 33 up to 330lb foodstuff containing added pectin daily before reaching the MADL threshold of methanol originating from the added pectin)
- OEHHA confirmed that the possible endogenous formation of methanol from added pectin does not constitute an exposure within the meaning of Proposition 65.
[i] http://oehha.ca.gov/prop65/prop65_list/files/P65single031612.pdf; https://oehha.ca.gov/media/downloads/proposition-65/chemicals/ig12001methanol.pdf
[ii] ADI “not specified”: A term applicable to a food substance of very low toxicity which, on the basis of the available data (chemical, biochemical, toxicological, and other), the total dietary intake of the substance arising from its use at the levels necessary to achieve the desired effect and from its acceptable background in food does not, in the opinion of JECFA, represent a hazard to health.
