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 phthalates in FCMs.1
Strict regulations also apply to other product categories, such as consumer products, clothing, and cosmetics. Measurlabs offers the necessary testing to verify that phthalate content and migration from materials do not exceed the limits outlined in EU legislation.
Table of contents
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, toys, 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 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 identified as 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. Some ortho-phthalates, such as bis(2-ethylhexyl) phthalate (DEHP) and dicyclohexyl phthalate (DCHP), are also harmful to the environment.3
The hazard classifications for selected phthalates restricted under EU chemicals legislation are summarized in Table 1.4
Table 1: Selected phthalates and their hazard classifications in the EU
Substance | Abbreviation | CAS No. | Hazard classification under REACH & CLP* | Properties of concern |
Bis(2-ethylhexyl) phthalate | DEHP | 117-81-7 | May damage fertility, may damage the unborn child, very toxic to aquatic life | Toxic to reproduction, endocrine-disrupting |
Benzyl butyl phthalate | BBP | 85-68-7 | May damage the unborn child, suspected of damaging fertility, very toxic to aquatic life | Toxic to reproduction, endocrine-disrupting |
Dibutyl phthalate | DBP | 84-74-2 | May damage the unborn child, suspected of damaging fertility, very toxic to aquatic life | Toxic to reproduction, endocrine disrupting, under assessment for persistent, bioaccumulative and toxic properties |
Diisobutyl phthalate | DIBP | 84-69-5 | May damage the unborn child, suspected of damaging fertility, toxic to aquatic life | Toxic to reproduction, endocrine disrupting, some evidence for persistent, bioaccumulative and toxic properties |
Dicyclohexyl phthalate | DCHP | 84-61-7 | May damage the unborn child, may cause an allergic skin reaction, very toxic to aquatic life | Toxic to reproduction, skin sensitizing, endocrine-disrupting |
Dioctyl phthalate | DNOP | 117-84-0 | Suspected of damaging fertility or the unborn child, may cause an allergic skin reaction, may cause allergy or asthma symptoms | Some evidence for skin sensitizing and respiratory sensitizing properties |
Diisodecyl phthalate | DIDP | 26761-40-0 | Very toxic to aquatic life | - |
Diisononyl phthalate | DINP | 68515-48-0 | - | - |
* REACH = Regulation (EC) No 1907/2006 on Registration, Evaluation, Authorisation and Restriction of Chemicals, CLP = Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.
How are phthalates restricted under REACH?
The REACH regulation, which together with the CLP Regulation forms the backbone of EU chemicals legislation, restricts the use of phthalates in several ways:
DEHP, DBP, BBP, and DIBP must not be used in most consumer articles.
DINP, DIDP, and DNOP must not be used in toys or childcare articles that children may place in the mouth.
Diisoheptyl phthalate, bis(2-methoxyethyl) phthalate, diisopentyl phthalate, di-n-pentyl phthalate (DPP), and di-n-hexyl phthalate (DnHP) must not be used in clothing, textiles, footwear, or accessories.
Phthalates classified as Category 1B reproductive toxicants (e.g., DEHP, BBP, and DBP) must not be placed on the market on their own or be used in substances or mixtures supplied to the general public.
The maximum concentration of restricted phthalates on their own or in combination with one another is, in most cases, 0.1% by weight of plasticized or homogenous material.5
Phthalate content exceeding the REACH regulation limit is a common reason for plastic toys and other consumer products being deemed dangerous and subsequently removed from the EU market.6 Manufacturers and importers can avoid unnecessary product recalls by having their products tested for phthalates before bringing them to market.
What are EU rules for 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 2.7
Table 2: 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.8
Similar maximum phthalate limits also apply to paper and board food contact materials that contain recycled fibers. The limits are outlined in German BfR Recommendation XXXVI, which is often used as a regulatory reference for EU compliance assessments due to the absence of harmonized legislation on fiber-based FCMs.9
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 products do not contain prohibited substances is a central part of the cosmetics safety assessment, which is required for marketing cosmetics 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
One partner for all your phthalate analysis needs
Testing for phthalates is generally carried out using gas chromatography–mass spectrometry (GC-MS) or tandem mass spectrometry (GC-MS/MS). Measurlabs offers a comprehensive range of testing options for different products and materials to ensure they meet regulatory restrictions on phthalate content and migration.
Some of our most popular services in this field include:
Phthalates analysis package for REACH compliance, covering substances on the REACH Authorization List.
Extended phthalates analysis for screening consumer products and packaging materials for a wider range of compounds. A low-detection-limit option (down to 0.00005 wt%) is available.
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, do not hesitate to contact us using the form below. When you include a few details about your samples and analysis objectives, we can prepare a quotation more quickly.
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 (ECHA) - Phthalates
3 Ibid.
4 The information is collected from ECHA’s Substance Infocards.
5 See entry 51, entry 52, and entry 72 of Annex XVII, and Appendix 12 to the consolidated version of Regulation (EC) No 1907/2006 for details on the restrictions. For the phthalates classified as class 1B reproductive toxins, the maximum limit is expressed as 1,000 mg/kg, which is numerically equivalent to 0.1% by weight.
6 According to the European Commission's Safety Gate rapid alert system for dangerous non-food products, 293 products were found to contain a non-compliant amount of phthalates during the year 2024. Most of these products were subsequently withdrawn from the market, subjected to a marketing ban, or destroyed.
7 The limits are outlined in Annex I to the consolidated version of Regulation (EU) No 10/2011.
8 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.
9 German Federal Institute for Risk Assessment, Annex to Recommendation XXXVI. Paper and board for food contact (Oct 2025). The main difference compared to the rules for plastic FCMs is the inclusion of a separate limit for DIBP (0.15 mg/kg).
10 Annex II of Regulation (EC) No 1223/2009.
11 European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER): updated guidelines on the benefit-risk assessment of phthalates in certain medical devices (2024).