Regulation of phthalates in plastics

Phthalates, also known as phthalate acid esters, are blends of more than 80 compounds. They are mainly used as plasticizers in various industries due to their ability to improve the flexibility and durability of plastics such as PVC.

The phthalates are not chemically bound which means that they can migrate from the product that contains them to food, the environment, or the user of this plastic.  This migration can occur through various routes of exposure including oral, pulmonary, and dermal.

The use of phthalates in plastics

Phthalates are widely used which is why now they can be found almost everywhere. Exposure to those substances can have negative effects on one’s health, including reproduction, the endocrine system and even kidney and liver functions.

Regulating phthalates

In order to guarantee the safety of both people and the environment, the use of phthalates in both Europe and the rest of the world is controlled with different rules and regulations regarding the type of product in which they can be used and their intended use.

The European Union and the Commission are working together with the member states and the European Chemicals Agency (ECHA) to evaluate and limit the risks of their chemical products to protect both human health and the environment.

With regard to phthalates, in 1999 the European Union established restrictions regarding their manufacture, commercialization and use in products such as toys or childcare products (TABLE 1).

Table 1: phthalates subject to restriction in the EU.

The Regulation REACH (EC) No 1907/2006 has also included DEHP, DBP, BBP and DIBP on the list of substances of very high concern (SVHC) due to their potential negative effects on reproduction, endocrine disruption and in the case of DEHP even the environment.

The REACH Annex XV also sorts phthalates from Table 1 according to their intended use. Entry 51 applies to every use of DEHP, DBP, BBP and DIBP while entry 52 focuses on toys and childcare products that include DINP, DIDP and DNOP. All these compounds cannot exceed a presence above 0.1% in the materials used for such products.

In the case of food contact materials, they must comply with the rules established in Regulation (EU) 10/1011. Said regulation authorizes the use of DEHP, BBP, DBP and DIDP phthalates for producing plastic layers and plastic materials and sets limits for maximum migration and the specifics of intended use.

In the 16th amendment, published in July 2023, the migration limits have been lowered and new classification groups have been added. Beside that DIBP has also now been included in the list. It is not an authorized additive; however, it can be present in small quantities as an impurity or due to having use as a supporting agent during the manufacture of certain types of plastics.

In that case a specific migration of phthalates is carried out on food simulants, as established by the legislation. Due to the last amendment lowering the migration limits as well as the complexity of phthalate extraction, complying with the more restrictive legislation has become a challenge for laboratories.

Lastly, regarding protecting the environment, there is a German certification called Blue Angel that was established more than 45 years ago. Blue Angel establishes strict standards for products and services that are environmentally friendly. Among those standards is the limit of concentration of certain materials such as the regulation Blue Angel DE-UZ 30 that applies to recycled plastics and included the monitorization of at least 11 phthalates.

AIMPLAS experience

AIMPLAS offers assessment services and  our analysis laboratories to help companies comply with the different standards and protocols related with phthalates. Do not hesitate to contact us if you have any questions or concerns.