The European Food Safety Authority (EFSA) recently reassessed the public health concerns relating to the use of phthalates as plasticizers in food contact materials (FCMs). Following the assessment, the Commission decided to introduce new, more stringent rules for using phthalates in FCMs.1 Strict regulations also apply to other product categories, such as cosmetics, toys, and consumer products.
Measurlabs offers the necessary testing to verify that phthalate content and migration from materials do not exceed the limits outlined in EU legislation.
What are phthalates?
Phthalates are a family of chemicals that are widely used in industry and consumer products. They are mainly used as plasticizers to increase the flexibility and durability of plastics like PVC, but they can also be found in adhesives, sealants, and paints. Examples of phthalate-containing products include wires, flooring, packaging, footwear, food contact materials, medical devices, and sports equipment. Phthalates can leach out of these materials, leading to exposure through food, skin, and air.2
What are the health concerns?
Several members of the phthalates family may damage fertility or the unborn baby, impact the hormonal system, and cause asthma. Pregnant women and young children have been found the most vulnerable groups. A particular concern is that some phthalates can affect the sexual development of boys, leading to infertility when they are adults.3
Some ortho-phthalates, such as bis(2-ethylhexyl) phthalate (DEHP) and dicyclohexyl phthalate (DCHP), are also harmful to the environment.4
EU regulations on phthalates in food contact materials
Five phthalates are authorized for use in plastic food contact materials as plasticizers or technical support agents, subject to restrictions outlined in the most recent consolidated version of the Plastics Regulation (EU) 10/2011. Generally, phthalates can be used in materials that do not come into contact with fatty foods or foods meant for infants or young children. The individual migration limits and maximum concentrations as technical support agents are summarized in Table 1.5
Table 1: Conditions for the use of phthalates in plastic food contact materials
FCM number | Substance | Migration limit | Max. concentration as a technical support agent |
|---|---|---|---|
157 | phthalic acid, dibutyl ester (DBP) | 0.12 mg/kg | 0.05% (w/w) |
159 | phthalic acid, benzyl butyl ester (BBP) | 6 mg/kg | 0.1% (w/w) |
283 | phthalic acid, bis(2-ethylhexyl) ester (DEHP) | 0.6 mg/kg | 0.1% (w/w) |
728 | phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60% C9 (DINP) | 1.8 mg/kg* | 0.1% (w/w) |
729 | phthalic acid, diesters with primary, saturated C9-C11 alcohols, more than 90% C10 (DIDP) | 1.8 mg/kg* | 0.1% (w/w) |
*This limit applies to the sum of FCM 728 and FCM 729.
In addition to the individual migration limits, a group limit of 0.6 mg/kg applies to the sum of DBP, BBP, DEHP, and diisobutyl phthalate (DIBP), expressed as DEHP equivalents.6
REACH restrictions on phthalates use
The REACH regulation restricts the use of phthalates in several ways. For example, DEHP, DBP, BBP, and DIBP shall not be used individually or in combination with each other in concentrations exceeding 0.1% by weight in most consumer articles, while DINP, DIDP, and di-n-octyl phthalate (DNOP) must not be used in greater concentrations in toys or childcare articles that can be placed in the mouth by children.7 In total, the maximum limit of 0.1% concentration applies to 14 phthalates.8
Phthalate content in excess of the REACH regulation limit is a common reason for plastic toys and other consumer products being removed from the EU market.9 Manufacturers and importers can avoid unnecessary product recalls by having their products tested for phthalates before bringing them to market.
Phthalates in cosmetics
Several phthalates are prohibited from use in cosmetics by the EU Cosmetics Regulation.10 These include:
Dibutyl phthalate (DBP)
Bis(2-ethylhexyl) phthalate (DEHP)
Bis(2-methoxyethyl) phthalate (DMEP)
N-pentyl-isopentylphthalate
Di-n-pentyl phthalate (DnPP)
Diisopentylphthalate (DIPP)
Benzyl butyl phthalate (BBP)
Diisobutyl phthalate (DIBP)
Dihexyl phthalate (DnHP)
Dicyclohexyl phthalate (DCHP)
Diisohexyl phthalate (DIHP)
Diisooctyl phthalate (DIOP)
Demonstrating that the product does not contain prohibited substances is a central part of the cosmetics safety assessment, which is required for marketing products within the EU.
Phthalates in medical devices
In principle, the EU Medical Device Regulation makes it possible to use phthalates with potentially carcinogenic, mutagenic, toxic to reproduction, or endocrine-disrupting properties in medical devices in concentrations higher than 0.1% by weight. This is only allowed, however, when justified by extensive risk-benefit analysis, including exploring other material options.11
Phthalates analysis
Testing for phthalates is generally carried out by gas chromatography-mass spectrometry (GC-MS) analysis. Measurlabs offers a variety of testing options, including the following:
Phthalates analysis package for REACH compliance, covering substances on the REACH Authorization List
Extended phthalates analysis for screening consumer products and materials for a wider range of compounds
Specific migration testing for assessing the transfer of phthalates from FCMs into food
Chemical characterization of medical devices, including an estimate of extractable and leachable phthalates
If you need testing or have any questions about the process, please contact us through the form below or at info@measurlabs.com. One of our experts will get back to you within one business day.
References:
1 EFSA’s updated risk assessment from 2019 can be found here. The changes are outlined in Commission Regulation (EU) 2023/1442, which was passed to amend Regulation (EU) 10/2011 in July 2023.
2 European Chemicals Agency - Phthalates
3 Ibid.
4 Ibid.
5 The limits are outlined in Annex I to the consolidated version of Regulation (EU) No 10/2011.
6 Group restriction 36, Table 2 of Annex I to the consolidated version of Regulation (EU) No 10/2011. The sum is calculated using the equation DBP*5 + DIBP*4 + BBP*0.1 + DEHP*1. DIBP is not an authorized additive, but it may be present as an impurity.
7 Annex XVII of Regulation (EC) No 1907/2006, sections 51 and 52. There are exceptions for certain product groups, such as medical devices.
8 Some of the restrictions are listed in Annex XVI, some in Annex XVII, and some in Appendix 12 of Regulation (EC) No 1907/2006. Appendix 12 lists the limits in 1,000 mg/kg instead of 0.1%.
9 According to the European Commission's Safety Gate rapid alert system for dangerous non-food products, 183 products were found to contain a non-compliant amount of phthalates between January and September of 2023. Most of these products were subsequently withdrawn from the market, subjected to a marketing ban, or destroyed.
10 Annex II of Regulation (EC) No 1223/2009
11 European Commission Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties.