Los ftalatos forman una familia de sustancias químicas sintéticas con una amplia variedad de usos, desde productos de consumo a productos industriales. Existen diferentes tipos de ftalatos, que se utilizan habitualmente como suavizantes para hacer que los plásticos, como el PVC, sean más flexibles y duraderos.
Debido a su amplio uso, los ftalatos pueden encontrarse casi en todas partes en nuestro medio ambiente. No se han estudiado a fondo todos los ftalatos, pero hay pruebas de que algunos de ellos son perjudiciales para la salud, ya que, por ejemplo, pueden interferir en nuestros sistemas hormonales y causar alergias. Como consecuencia de ello, el uso de determinados ftalatos ya está regulado tanto en Europa como en todo el mundo.
Although phthalates are mostly used as plasticisers, they can also be found in, for example, adhesives, sealants, paints, rubber materials, wires and cables, flooring, packaging, food contact materials, medical devices and sports equipment.
The most known phthalates are ortho-phthalates, such as bis(2-ethylhexyl) phthalate (DEHP) and di-''isononyl'' phthalate (DINP).
We are exposed to phthalates through food, skin, and air. As phthalates are not chemically bound in the materials they are added to, they can easily leach out or evaporate.
Several ortho-phthalates, for example DEHP, dibutyl phthalate (DBP), diisobutyl phthalate (DIBP) and benzyl butyl phthalate (BBP) may damage fertility or the unborn baby and interfere with our hormonal system. In particular, they affect the sexual development of boys which can lead to infertility in adults.
Apart from boys, pregnant women and young children in general have been found to be the most vulnerable groups to the effects of phthalates.
Some ortho-phthalates, such as DBP, BBP, and DEHP, are also harmful to the environment.
Harmonised classification and labelling
Several ortho-phthalates, including DEHP, DBP, DIBP and BBP, are classified as toxic to reproduction (Repr. 1B). This means that they are presumed to have a negative effect on our ability to have children and on the unborn baby.
DBP and BBP are classified as very toxic to aquatic life (aquatic acute 1) and BBP also as very toxic to aquatic life with long lasting effects (aquatic chronic 1).
Assessing groups of phthalates
ECHA has assessed data on four groups of phthalates and phthalate-like substances:
- terephthalates; and
Assessing structurally similar substances in groups speeds up identification of those substances which may need to be regulated. It also helps companies to avoid replacing hazardous chemicals by others with a similar concern.
Based on the assessment, the use of many ortho-phthalates may need to be limited in the future. Some will need harmonised classification and labelling or identification as substances of very high concern (SVHC). But there are also phthalates for which more data is needed to confirm the potential hazard, and for a few no regulatory actions are needed for the time being.
Substances of very high concern and REACH authorisation
The Candidate List of substances of very high concern (SVHC) contains several ortho-phthalates that are harmful for reproduction. Among those, five ortho-phthalates are identified as substances of very high concern also due to their endocrine disrupting properties - DIBP, DBP, BBP, DEHP, dicyclohexyl phthalate (DCHP) for human health, and DEHP and DCHP also for the environment.
Producers and importers of articles have to notify ECHA if their article contains a substance on the Candidate List within six months after the substance has been included in the list.
Altogether 14 phthalates are on the REACH Authorisation List. If a substance is placed on the Authorisation List, after a given date its use will be prohibited unless the European Commission authorises the company to continue its use. When applying for authorisation the company needs to demonstrate that the use of the substance is controlled, that there are no suitable alternatives and the benefits of continued use exceed the risks.
In November 2021, the Commission added endocrine disrupting properties to DEHP, DBP, BBP and DIBP, which were originally added to the list for being toxic to reproduction. The update of hazard properties to cover hormonal effects means that companies will need to apply for REACH authorisation for some uses that were previously exempted. These include, for example:
- uses of DEHP, for example in food contact materials, medical devices and immediate packaging of medicinal products (due to the hazards to the environment), and
- uses of BBP and DBP in immediate packaging of medicinal products.
Phthalates that are classified as toxic to reproduction (Repr. 1B) are restricted on their own and in mixtures that are intended for consumer use.
DEHP, DBP, DIBP and BBP are restricted in a wide range of products since July 2020. These include for example children’s swimming aids, flooring, coated fabrics and paper, recreational gear, mattresses, footwear, and office supplies. The restriction is expected to save about 2 000 boys each year from impaired fertility later in life.
Due to their EU-wide classification as toxic to reproduction, several phthalates are also restricted since November 2020 in consumer clothing or related accessories as well as in other textiles that come into contact with the skin. Phthalates covered by this restriction include: DEHP, DBP, DIBP, BBP, diisopentylphthalate 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich, bis(2-methoxyethyl) phthalate, dipentyl phthalate, and dihexyl phthalate.
The restrictions also regulate the import of articles containing these phthalates.
Since 1999, the use of six phthalates, DINP, DEHP, DBP, di-"isodecyl" phthalate (DIDP), dioctyl phthalate (DNOP) and BBP, in children’s toys was prohibited under a temporary ban. In 2007, a permanent ban started to apply. This ban also broadened the scope to include childcare products that small children can put in their mouths. In January 2018, the restriction was further expanded to include DIBP.
Since July 2011, all phthalates classified as reprotoxic have generally been prohibited in toys and components of toys.
Waste Framework Directive
Old plastic items can still contain some of the phthalates that are no longer allowed to be used. This creates a challenge for circular economy as these phthalates first need to be detected and removed before the material can safely be recycled or reused.
Since 5 Jan 2021, the Waste Framework Directive requires manufacturers, importers and distributors of products containing substances of very high concern to notify about these products to ECHA’s SCIP database. Products containing phthalates that are on the REACH Candidate List must be notified.
Anyone can search the SCIP database to find products that contain certain phthalates. This is expected to help, for example, waste treatment operators in their daily work and will, in turn, contribute to circular economy. With more information available on hazardous chemicals, consumers can make more informed choices when buying products. Companies are also encouraged to use the information in SCIP database when considering how to replace such harmful substances.
Hazardous substances in electrical and electronic equipment
The restriction of hazardous substances in the electrical and electronic equipment (RoHS) directive prohibits BBP, DBP, DEHP and DIBP in most electronic and electrical equipment since 22 July 2019. Products containing these chemicals are not allowed to be sold on the EU market. However, the restriction does not apply to products such as medical devices and control instruments that have been placed on the market before 22 July 2021.
Plastics in food packaging
The European Food Safety Authority (EFSA) assessed DBP, BBP, DEHP, DINP and DIDP in food contact materials in 2005 and again in 2019, considering new scientific evidence. The latest review introduced a tolerable daily intake level for the group of DBP, BBP, DEHP and DINP taking into account combined exposure to these phthalates. It was set on a temporary basis due to limitations and uncertainties identified in the assessment. The exposure to DBP, BBP, DEHP, DINP from food was found to be seven times below group safe level – while for DIDP the dietary exposure is 1 500 times below its safe level.
To follow up on the 2019 review, the European Commission has requested EFSA to conduct preparatory work ahead of the re-evaluation of the risks to public health from plasticisers such as phthalates used in food contact materials.
- First assessments of regulatory needs for groups of chemicals published
- Assessment of regulatory needs list
- Safer Chemicals Podcast: Assessing chemicals in groups – faster action on harmful chemicals
- Endocrine disrupting properties to be added for four phthalates in the Authorisation List
- Call for evidence for 10 phthalates, DL 26 Jan 2022
- Harmonised classification and labelling
- Chemicals in plastic products
- Candidate List obligations
European Commission and EU institutions
- Amendment of Annex XVII to REACH as regards certain substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), category 1A or 1B
- Amendment of the REACH Authorisation List for DEHP, DBP, BBP and DIBP
- EFSA's news: Phthalates and other plasticisers: priorities for reassessment
- EFSA's topical page: Food contact materials