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Phthalates in consumer products

P rov i d i n g a n i n s i g h t i n to t h e re g u l a t i o n s s u r ro u n d i n g t h e p re s e n c e o f p h t h a l a t e p l a s t i c i s e r s .

Image © art-4-art | iStockphoto.com

Phthalates are a group of chemical plasticisers that are frequently added to polymer formulations to change
the flexibility and durability of the final plastic. These substances are commonly used to soften polyvinyl
chloride (PVC), combatting the naturally very rigid and hard properties of unplasticised PVC (‘uPVC’) to
create a much softer and malleable final material.

Their use is not only confined to PVC, as polyurethane (PU), paint, inks and adhesives can also contain
phthalate plasticisers. In addition, plasticised materials can be found in many products, including polymeric
footwear solings, plastic packaging, children’s toys, personal protective equipment (PPE) and other
consumer products.

Phthalate plasticisers alter the physical properties of the plastics by weakening the bonds between the
polymer chains. This makes them not so tightly bonded to each other, which results in increased flexibility.
The oils in plasticisers are not chemically bound to the polymer, but lie between the polymer strands. This
results in plasticisers being highly mobile, creating a potential migration pathway for discolouration
problems where dark-coloured materials can transfer their colour to light-coloured materials.
Health concerns
Concerns have been raised about phthalate plasticisers, due to possible hormonal effects on people who are
exposed to them over a period of time. As such, these substances are described as ‘endocrine disruptors’.
Exposure to phthalates can occur through various routes, the most concerning being ingestion, which
makes infants most at risk of being exposed due to their hand-to-mouth behaviour. This is why the first
phthalate restrictions only applied to toys and childcare items. However, as a result of more research data
being produced, this is no longer the case, as it has been identified that exposure to these phthalates can be
through a number of different routes of exposure.

Therefore, children are no longer the only demographic considered to be at risk. The research stated that not
only does exposure occur through ingestion, but also via prolonged contact with skin and inhalation of air in
indoor environments. The study revealed that there was a risk not only for the consumer but also the worker.
Hence, the European Chemical Agency (ECHA) decided to widen the scope and amend REACH (Regulation
(EC) No 1907/2006) Annex XVII entry 51, covering restrictions on plasticised toys or childcare items, to any
article containing plasticised materials. Detailed information about phthalates that are restricted can be
found in this article.

Alternatives to phthalates
There are other chemicals which can be used as plasticisers instead of phthalates. These include adipate-
based plasticisers which are used for low-temperature applications, and other aliphatic esters based on
dicarboxylic acids, such as sebacates and maleates. There are also moves towards natural plasticisers,
including epoxidised vegetable oils. However, when switching to an alternative plasticiser system, there may
be a need to alter the plasticiser level and possibly the production process, as each individual plasticiser will
behave differently and modify the handling properties of a polymer to differing degrees.

The wide range of uses of PVC and other plasticised compounds in the manufacture of footwear, apparel,
luggage, PPE and other consumer products will place different demands on materials in terms of
performance. Product specifications need to evaluate key physical parameters. This will help to ensure that
any move away from phthalate plasticisers meets the requirements of the consumer’s expectations for the
intended level of performance from the material and the finished product.

European restrictions
REACH Annex X VII. Specific phthalates are restricted in Europe under REACH Annex XVII entries 51, 52 and
72, and in the UK under UK REACH which currently matches the EU REACH requirements. Since July 2020,
DEHP, BBP, DBP and DIBP have been restricted in articles containing plasticised materials at 0.1 per cent or
above by mass under entry 51. The article should not be placed on the market if either the individual
concentration of each phthalate, or the sum of the four phthalates in the plasticised material, is greater than
0.1 per cent.

Under entry 52, DINP, DIDP and DNOP are restricted in toys and childcare articles which can be placed in the
mouth by children in concentrations greater than 0.1 per cent by weight of the plasticised material. A
‘childcare article’ is defined as any product ‘intended to facilitate sleep, relaxation, hygiene, the feeding of
children or sucking on the part of children’. A summary of the entry 51 and 52 restrictions is detailed in table
1 below.
 Table 1: Phthalate restrictions listed in REACH
Regulation (EC) 1907/2006 Annex XVII entries 51
and 52
Phthalate A c ron y m CAS number

Bis (2-ethylhexyl) phthalate DEHP 117-81-7

Dibutyl phthalate DBP 84-74-2

Benzyl butyl phthalate BBP 85-68-7

Di-isobutyl phthalate DIBP 84-69-5

Di-isononyl phthalate DINP 28553-12-0

and 68515-48-0

Di-isodecyl phthalate DIDP 26761-40-0

and 68515-49-1

Di-n-octyl phthalate DnOP 117-84-0

Entry 72 concerns substances that are classified as ‘carcinogenic’ (may cause cancer), ‘mutagenic’ (may be
capable of inducing genetic mutation) or classified as toxic for reproduction, and includes 33 different
substances. Five phthalates are restricted to a maximum of 1,000 mg/kg (individually or sum of the
phthalates) and the scope of the restriction applies to textile materials in footwear and clothing (see table 2).

Table 2: Phthalate restrictions listed in REACH

Regulation (EC) 1907/2006 Annex XVII entry 72
Phthalate A c ron y m CAS number

1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl DIHP 71888-89-6

esters, C7-rich (also known as Di-isoheptyl phthalate)

Bis(2-methoxyethyl) phthalate DMEP 117-82-8

Di-n-hexyl phthalate DnHP 84-75-3

Di-n-pentyl phthalate DnPP (DPENP) 131-18-0

Di-isopentyl phthalate DIPP 605-50-5

REACH SVHCs. ‘Substances of Very High Concern’ (SVHCs) fall under the ‘authorisation’ category of
REACH. This process aims to ensure that substances associated with health or environmental concerns are
progressively replaced by less dangerous options.

There are currently 16 phthalates listed as SVHCs as indicated in table 3.

 Table 3: Phthalates included in the Candidate List of
Substances of Very High Concern (SVHC) published
on 14th June 2023
Phthalate A c ron y m CAS number

Bis (2-ethylhexyl) phthalate DEHP 117-81-7

Dibutyl phthalate DBP 84-74-2

Benzyl butyl phthalate BBP 85-68-7

Di-isobutyl phthalate DIBP 84-69-5

1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl DIHP 71888-89-6

esters, C7-rich (also known as Di-isoheptyl phthalate)

Bis(2-methoxyethyl) phthalate DMEP 117-82-8

Di-n-hexyl phthalate DnHP (DHEXP) 84-75-3

Di-n-pentyl phthalate DnPP (DPENP) 131-18-0

Di-isopentyl phthalate DIPP 605-50-5

Dicyclohexyl phthalate DCHP 84-61-7

1,2-Benzenedicarboxylic acid, di-C7-11-branched and DHNUP 68515-42-4

linear alkyl esters

1,2-Benzenedicarboxylic acid, dipentylester, branched PP* 84777-06-0

and linear

n-pentyl-isopentyl phthalate PIPP 776297-69-9

1,2-Benzenedicarboxylic acid, dihexyl ester, branched DHP 68515-50-4

and linear

Di-isohexyl phthalate DIHxP 71850-09-4

bis(2-ethylhexyl) tetrabromophthalate covering any of _ 26040-51-7

the individual isomers and/or combinations thereof

*PP is the sum of DIPP, DnPP and PIPP

Suppliers of articles containing any SVHCs at a concentration greater than 0.1 per cent by weight of the
entire article must identify them to their customers and give sufficient information to ensure the product is
used safely. Notification to ECHA in the EU and the Health and Safety Executive (HSE) in the UK is also
required if, in addition to the 0.1 per cent limit being exceeded, the total amount of the SVHC being imported
into either the EU or UK market is greater than one tonne per annum.
US restrictions
CPSI A. There is also phthalate legislation specific to the USA. This is contained within Section 108 of the
Consumer Product Safety Improvement Act of 2008, which is commonly referred to as the ‘CPSIA’. The
CPSIA is enforced by the Consumer Product Safety Commission (CPSC) and requires importers and
manufacturers to comply with Federal legislation, which includes specific limits for the amount of phthalates
that children’s toys and childcare articles can contain.

CPSIA section 108 (as updated by 82 FR 49938), requires less than 0.1 per cent of eight phthalates: DEHP,
DBP, BBP, DINP, DnPP, DnHP, DCHP and DIBP, to be present (see table 4). Under this legislation, a child’s toy is
considered to be ‘a consumer product designed or intended by the manufacturer for a child 12 years of age
or younger, for use by the child when the child plays’. A childcare article is defined as ‘a consumer product
designed or intended by the manufacturer to facilitate sleep or the feeding of children age three and younger,
or to help such children with sucking or teething’.

Table 4: Phthalate restrictions listed in Section 108

of the Consumer Product Safety Improvement Act
of 2008
Phthalate A c ron y m CAS number

Bis (2-ethylhexyl) phthalate DEHP 117-81-7

Dibutyl phthalate DBP 84-74-2

Benzyl butyl phthalate BBP 85-68-7

Di-isononyl phthalate DINP 28553-12-0

(68515-48-0)

Di-isobutyl phthalate DIBP 84-69-5

Di-n-pentyl phthalate DnPP (DPENP) 131-18-0

Di-n-hexyl phthalate DnHP (DHEXP) 84-75-3

Dicyclohexyl phthalate DCHP 84-61-7

The CPSIA requires that all US manufacturers and importers must produce a Children’s Product Certificate
(CPC). These certificates must be based on test reports from CPSC-accredited, independent third-party
laboratories which are both accredited to ISO 17025 and are listed on the CPSC website. SATRA has such a
facility, and our accredited laboratory identification number is 1223.

Exemptions from compulsory testing are granted to materials comprised of polyethylene (PE), polypropylene
(PP), general purpose polystyrene (GPPS), medium impact polystyrene (MIPS), high impact polystyrene
(HIPS), super high impact polystyrene (SHIPS) and acrylonitrile butadiene styrene (ABS), as long as the
formulations demonstrate that the restricted phthalates were not used.

Californian Proposition 65. ‘Proposition 65’ (also known as the ‘Safe Drinking Water and Toxic Enforcement
Act’) was published in 1986 as legislation applicable to the US state of California. This was brought into
force as a way of informing citizens about exposures to chemicals that could cause cancer, birth defects or
other reproductive harm. Proposition 65 requires suppliers to label their products containing chemicals
identified as being carcinogenic or having adverse effect on development or reproductive health. The list is
published by the Office of Environmental Health Hazard Assessment (OEHHA) and it is required to be
updated at least annually. There are currently over 900 chemicals on the list.

The key requirement of Proposition 65 is for suppliers of consumer goods to ensure that a ‘clear and
reasonable’ warning is provided to consumers if any of the substances listed are known or suspected to be
present. In some cases, warnings are not required for products, even if they contain substances listed within
Proposition 65. This occurs where the company can demonstrate that the level of exposure does not carry a
significant risk. There are currently six phthalates included in Proposition 65 (see table 5).

Table 5: Phthalates listed in California Proposition 65

Phthalate A c ron y m CAS number

Bis (2-ethylhexyl) phthalate DEHP 117-81-7

Dibutyl phthalate DBP 84-74-2

Benzyl butyl phthalate BBP 85-68-7

Di-isononyl phthalate DINP 28553-12-0

and 68515-48-0

Di-isodecyl phthalate DIDP 26761-40-0

and 68515-49-1

Di-n-hexyl phthalate DnHP (DHEXP) 84-75-3

Testing for phthalates

The most commonly followed international testing standards to determine whether phthalates are present
are EN ISO 16181:2021 (part 1 with solvent extraction and part 2 without solvent extraction) for ‘critical
substances potentially present in footwear and footwear components’, and EN ISO 14389:2022 – ‘Textiles –
Determination of the phthalate content – Tetrahydrofuran method’. EN ISO 14389 was updated in 2022 and
included a broader list of phthalates to detect alongside some other minor changes. SATRA is able to carry
out testing to the 2022 version of EN ISO 14389, as well as CPSC-CH-C1001-09.4 to comply with the CPSC
requirements for phthalates in the USA.

Steps to compliance
Demonstrating that restricted phthalates are not present is mandatory for all consumer products sold within
the EU, UK and in California, as well as for children’s items sold in the USA. A helpful summary of the
restrictions discussed in this article can be found in table 6. There are a number of steps that can be taken to
ensure that products comply with the requirements of restrictions. The auditing of raw materials and
production processes, exchanging technical information throughout the supply chain and supplier
declarations of conformity can all be used to provide information and assurance that restricted phthalates
are not present in consumer products.
Table 6: Summary
Phthalate REACH Annex X VII REACH CPSI A P ro p
SVHC 2008 65
entry 51 entry 52 entr y 72

DEHP √ √ √ √

DBP √ √ √ √

BBP √ √ √ √

DIBP √ √ √

DINP √ √ √

DIDP √ √

DnOP √

DnHP √ √ √ √

DIHP √ √

DMEP √ √

DnPP √ √ √

DIPP √ √

DCHP √ √

DHNUP √

PIPP √

DIHxP √

PP √

DHP √

bis(2-ethylhexyl) √
tetrabromophthalate
covering any of the individual
isomers and/or combinations
thereof
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©2023 SATRA Technology Centre. Reproduction is not permitted in any form without prior written permission from SATRA.