How are phthalates regulated in food contact materials in Europe and the United States?
With regard to phthalates, EFSA has actually done quite a bit of assessment work. As early as 2005, EFSA conducted a scientific assessment of five common phthalate substances and published a scientific opinion. The five substances, DBP, BBP, DEHP, DINP and DIDP, were subsequently included in the positive list of the EU Plastics Regulation (EU) 10/2011.
What are phthalates?
Phthalates are a class of chemicals used to soften and increase plastic plasticity and are used in a wide range of consumer products, such as toys, detergents, lubricants, pharmaceuticals, blood bags and pipes, as well as personal care products, such as nail polish, hairspray, shampoo, perfume and other fragrances.
Food packaging field naturally there is no shortage of phthalate plasticizers, such as PVC plastics, polyolefin plastics and so on.
What are the dangers of phthalates?
According to the &ldquo issued by EFSA; Scientific opinion on the use of DEHP in food contact materials ” In animal experimental studies, it was found that phthalates were associated with reduced fertility, reproductive toxicity and testicular toxicity.
According to the National Institute of Environmental Health Sciences, phthalates interfere with the body's hormone production mechanisms, disrupt the endocrine system, and have been linked to development, reproduction, the brain, immunity, and other problems.
In addition, increased levels of phthalates have been found to be associated with adverse health effects in the population, such as urinary phthalate metabolite concentrations found to be associated with obesity in adult males in the United States, and prenatal exposure to phthalates may lead to reduced masculinization of male infants.
Phthalates can appear in food?
The answer is yes.
Research carried out in the UK market has shown that phthalates may be present in food due to the migration of chemicals from food packaging and that everyone may ingest them through food.
In addition, the study found that one or more phthalates can be detected in different types of retail food packaging materials, such as glass jars with PVC washers, metal caps, plastic containers with foil LIDS, paper/foil/plastic laminates (beverage cartons), etc. At the same time, the study confirmed that non-PVC packaging may also be a source of phthalates.
Urgent need for regulatory action on phthalates
As the migration of phthalates in packaging materials has attracted increasing attention from consumers and the scientific community, the regulation of phthalates in various regions of the world has become increasingly severe.
Today, we will take five common phthalates as an example to take stock of how the mainstream market in Europe, China and the United States regulates the use of phthalates in food packaging materials.
The five phthalates are:
di-butylphthalate (DBP)
butyl benzyl-phthalate (BBP)
Di-phthalate (α bis(2-ethylhexyl)phthalate (DEHP)
di-isononylphthalate (DINP) Di-Isononylphthalate (DINP)
di-isodecylphthalate (DIDP) Di-Isodecylphthalate (DIDP)
Regulation of phthalates in Europe and the United States
European Union
With regard to phthalates, EFSA has actually done quite a bit of evaluation work. As early as 2005, EFSA conducted a scientific assessment of five common phthalate substances and published a scientific opinion. The five substances, DBP, BBP, DEHP, DINP and DIDP, were subsequently included in the positive list of the EU Plastics Regulation (EU) 10/2011. In light of new research evidence in recent years that phthalates may be toxic to reproductive development, EFSA has been asked to reassess the safe levels of five phthalates in plastic FCM and to assess whether current dietary exposure poses a public health concern. As a result, in 2019 EFSA published the results of a reassessment of the five phthalates mentioned above. In fact, the results of the reassessment are generally consistent with the scientific opinion given in 2005.
The main difference is:
Group Allowable Daily Intake (Group TDI) for four phthalates was introduced to cover simultaneous exposure to several phthalates.
Because dibutyl phthalate (DBP), butylbenzyl phthalate (BBP), bis (2-ethylhexyl) phthalate (DEHP) and diisononyl phthalate (DINP) are a co-acting mode of reproductive toxicity, Therefore, the 2019 edition of scientific opinion determined the Group TDI (Group TDI) for these four substances to be 50µ g/kg BW(Body Weight). The toxicity of the fifth substance DIDP is that it acts on the liver rather than reproductive toxicity, so the TDI is set separately at 150µ g/kg BW.
The current average dietary exposure to DBP, BBP, DEHP and DINP, as assessed by EFSA, is 7µ g/kg Body weight, less than 7 times the safe level, and the average dietary exposure to DIDP is less than 1500 times the safe level, so the daily exposure is low and does not have a significant impact on public health under the rational use of phthalates as required by regulations. As a result, these five phthalates are currently listed in the EU Plastics Regulation (EU)10/2011 and their restriction requirements have not changed.
The specific migration limits (SML) of DBP,BBP and DEHP in the EU list are 0.3, 30 and 1.5mg/kg respectively; The total specific migration limit (SML (T)) is 60mg/kg. The total specific migration limits for DINP and DIDP were 9mg/kg (as the sum of substances in group 26). 60mg/kg (sum of substances in group 32).
China
China's approach to the regulation of phthalates is similar to that of the EU, and a number of phthalates are also included in GB 9685-2016 "Additives for Food Contact Materials and Products". However, not all of the above five phthalates are included in GB 9685-2016, and the restrictions on use are different from those in the EU.
The main difference is:
When applied in plastic materials, GB 9685-2016 limits its use only in PVC plastics, and the EU plastics regulations do not limit its use;
For Di-isononylphthalate (DINP), CAS numbers 68515-48-0 and 28553-12-0 are listed in the EU list under the same FCM number.
In GB 9685-2016, the two substances are listed separately, corresponding to two FCA numbers, and their specific restrictions are also different.
BBP and DIDP are not included in GB9685-2016 and are not allowed to be used in food contact materials.
United States
A variety of phthalate chemicals are included in the positive list of Part 175-178 of the U.S. Food Contact Materials Regulation 21CFR.
It should be noted that although the above 5 phthalates have applications in adhesives, coatings, paper and cardboard, cellophane, polymer resins, reusable rubber products, etc., the intended use of each substance at the time of use and its use restrictions (eg. Type of contact food, amount of use, etc.) should strictly comply with the requirements of the relevant sections.
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