Phthalate Regulations in the United Kingdom: An Overview

Increasingly, phthalates are seen as dangerous when exposed to too much of them. Various jurisdictions, including the UK, are requiring importers and manufacturers to test their products for the presence of phthalates before allowing such products to be placed on the market.

In this article, we explain what phthalates are and why they are one of the more important substances to look out for when importing and manufacturing products in the UK. However, this article does not cover regulations in Northern Ireland.

What are Phthalates?

Also known as plasticizers, phthalates are a group of chemicals that are used on plastic products to alter their physical properties. They are also used as solvents or binding agents.

There has been increased focus on phthalates due to their widespread use in our everyday products, and because there are more and more studies that suggest that phthalates may cause long-term adverse health effects. Additionally, phthalates are considered to be dangerous for pregnant women and young children.

Examples

Here are some phthalates compounds that are commonly found in everyday products:

a. DBP – di-n-butyl phthalate (Found in nail polish products)

b. DEHP – di-(2-ethylhexyl) phthalate (Found in polyvinyl chloride (PVC) to make products more flexible)

c. DEP – diethyl phthalate (Found in personal care products to enhance fragrance)

d. DiNP – di-isononyll phthalate (Found in softener in the manufacture of toys and childcare products)

Some jurisdictions restrict, or in some cases ban, the importation and manufacturing of various phthalates.

Are Phthalates banned in the United Kingdom?

Not all phthalates are banned from use in the United Kingdom. Additionally, even phthalates that are prohibited or restricted in certain regulated products may be permitted in other products (e.g medicinal products, etc).

However, increasingly new phthalates are being regulated for various products. Thus, importers and manufacturers should be vigilant for future regulatory changes.

Which products and materials may contain Phthalates?

Some call it “the everywhere chemical” because of the prevalence of phthalates in everyday products.

To illustrate this, here are some of the product categories that may contain phthalates:

• Plastic toys
• Coatings
• Cosmetics and personal care
• Wood finishes
• Detergents
• Adhesives
• Plastic FCMs and other plastic materials
• Lubricants
• Solvents
• Insecticides
• Building materials

UK REACH

The UK REACH regulations regulate chemicals and heavy metals found in products manufactured or imported to the UK market. The regulations provide for the registration, evaluation, authorisation, and restriction of certain substances for the sake of safety.

It should be noted that the UK REACH regulations are similar to the EU regulations (for instance, the UK adopted the EU REACH’s list of restrictions). However, with the passing of time, there may be differences as post-Brexit the UK REACH are completely separate from its EU counterpart.

Product scope

The UK REACH covers most chemicals and heavy metals, including phthalates, in their standalone form, in mixtures, and in their form as an article (i.e. consumer products).

Here are some product categories that would be affected by the regulations:

• Toys
• Electronic products
• Plastic FCMs and other plastic materials
• Cosmetics and personal care

Most products that may contain phthalates are covered by the UK REACH regulations.

Phthalates restrictions

As previously mentioned, the regulations restrict certain substances by setting out limits for use, bans or conditions on manufacturers and importers. Such restricted substances include phthalates.

The following are examples of phthalates restricted in the UK:

DPP and DnHP

These phthalates are found in entry 72 and contain maximum concentration limits by weight in homogenous material at 1000 mg/kg for the named substances in clothing, textiles and footwear products.

BBP, Diisobutyly phthalate, and others

These phthalates are found in entry 30 which contains substances that are toxic to reproduction. Such listed phthalates must not be placed on the market or used for supply to the general public, unless by way of derogation.

Again, importers and manufacturers should be vigilant to changes in phthalate restrictions.

Additional limitations on children’s products

Concerning toys and childcare articles, the following phthalates are practically banned.

DEHP, BBP, and DIBP

These phthalates are found in entry 51 and restrict importers and manufacturers from placing on the market articles containing the four phthalates in a concentration equal to or above 0.1% by weight individually or in any combination in any plasticised material

DINP, DIDP, and DNOP

These phthalates are found in entry 52 and importers and manufacturers must not use the listed phthalates as substances or in mixtures, in concertations greater than 0.1% by weight of the plasticised material which can be placed in the mouth of children

Again, it should be noted that not all phthalates are regulated, but may be added to the list of restrictions, candidate list or authorization list.

Regulation (EC) No 1223/2009 on Cosmetic Products

Regulation (EC) No 1223/2009 on cosmetic products is a retained EU legislation by operation of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. This means that even after Brexit, the content of the EU regulation is still relevant and should be observed.

The EU regulation is enforced by the Cosmetic Products Enforcement Regulations 2013. The regulations ensure that cosmetic products placed in the UK market are safe, and it imposes labelling and technical documentation requirements for importers and manufacturers.

Product scope

A cosmetic product refers to any substance or mixture intended for contact with the human body’s external parts or with the teeth and the oral cavity’s mucous membranes and is used exclusively or mainly to:

• Clean them
• Perfume them
• Change their appearance
• Protect them
• Keep them in good condition
• Correct body odours

If the product is made to have substances or mixtures enter the human body (e.g. by ingestion, inhalation, etc), then it may not be a cosmetic product.

Phthalates restrictions

Annex II of Regulation (EC) No 1223/2009 contains a list of prohibited substances, including a number of phthalates. Here are a few phthalates that are prohibited along with their reference number:

• Reference number 675 – Dibutyl phthalate
• Reference number 677 – bis(2-Ethylhexyl) phthalate (Diethylhexyl phthalate)
• Reference number 678 – bis(2-Methoxyethyl) phthalate
• Reference number 1152 – Benzyl butyl phthalate (BBP)

Note that importers and manufacturers can expect an update to the regulation as ‘The Toys and Cosmetic Products (Restriction of Chemical Substances) Regulations 2022’. This will include newly prohibited phthalates:

• Reference number 1653 – Diisohexyl phthalate
• Reference number 1667 – Diisooctyl phthalate

Said updates will take full effect on the 15th of October, 2022.

Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations

The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 (RoHS) is legislation that sets out essential requirements which, if met, would enable the importer or manufacturer to place electrical products in the UK market.

Some of these essential requirements restrict the use of certain hazardous substances, including phthalates in electronic products.

Product scope

The legislation covers most EEE products, cables, and spare parts such as:

• Electric and electronic tools
• Electronic toys
• Electronic sports equipment
• IT and telecommunications equipment
• Other electronics

Phthalates restrictions

With regards to phthalates, the regulated ones and their maximum concentration value by weight in homogeneous materials are the following:

• Bis (2-ethylexyl) phthalate (DEHP) < 0.1%
• Butyl benzyl phthalate (BBP) < 0.1%
• Dibutyl phthalate (DBP) < 0.1%
• Diisobutyl phthalate (DIBP) < 0.1%

However, it should be noted that the restrictions do not apply to the following product categories:

a. Medical devices (including in vitro medical devices)

b. Monitoring and control instruments (including industrial monitoring and control instruments)

c. Cables or spare parts used for the electronic product placed on the market before the 22nd of July, 2019

Additionally, the restrictions do not apply to toys; but as the legislation states, the four phthalates are already subject to REACH restrictions through entry 51 of Annex 17.

Toys (Safety) Regulations

The Toys (Safety) Regulations 2011 aim to increase the level of safety among toy products placed in the UK market. It does this by imposing legal obligations on importers or manufacturers to adhere to “essential safety requirements”.

The regulations refer to the EU Toy Safety Directive.

Product scope

The regulation covers most toy products designed or intended for playing by children under 14 years old.

Here are a few examples of toy product categories that fall under the ambit of the regulation:

• Electronic toys
• Educational toys
• Plush toys
• Arts and crafts

Phthalates restrictions

Although the regulation does not mention phthalates, it refers to safety requirements set out in article 10 and Annex II in the toy safety directive that importers and obligations must adhere to.

Annex II directs us to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures which classifies substances as carcinogenic, mutagenic or toxic for reproduction (CMR) of categories 1A, 1B or 2. These substances must not be used in toys or their parts.

With reference to Regulation (EC) No 1272/2008, here are a few examples of prohibited phthalates:

• Diallyl phthalate
• Bis(2-methoxyethyl) phthalate
• Dibutyl phthalate (DBP)
• Benzyl butyl phthalate (BBP)

The Materials and Articles in Contact with Food Regulations

Food contact materials (FCMs) are affected by a number of regulations in the UK. Amongst them, regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food is relevant to phthalates.

Product scope

Here are some of the products that are affected by FCM regulations:

• Lunchboxes
• Electronic kitchen appliances
• Drinkware
• Cutlery
• Bowls
• Jugs
• Tableware

Phthalates restrictions

Regulation (EU) No 10/2011 lists authorized substances, which are the only substances that can be used during the manufacturing of plastic FCMs. The list can be found in Annex I of the legislation. Substances that are not listed as authorised substances cannot be used, unless by way of derogation.

The following are some phthalates found in Annex I along with their specific migration limits (SMLs) (expressed in mg substance per kg food) and other restrictions:

a. Tricyclodecanedimethanol bis(hexahydrophthalate) < 0.05 mg/kg

b. (PET, HTPB, PMDA) copolymer – no specific migration limits and it can only be used in PET at a maximum level of 5% w/w

c. Cyclic oligomers of (PBT) – no specific migration limits and it can only be used in certain plastics (like PET, PBT, PC, PS and PVC plastics) in concentrations of up to 1% w/w, in contact with aqueous, acidic and alcoholic foods, for long term storage at room temperature

For more information about other phthalates restrictions in FCMs, we recommend using the European Chemical Agency’s database and filtering the list with the word “phthalate” to identify the SMLs, specifications, and restrictions.

However, note there may be changes in the future between the UK and EU FCM regulations. Thus, one should be vigilant to any changes in UK legislation.

Children’s FCM: BS EN 14372 – Child use and care articles

In relation to FCM products, there are voluntary standards which importers and manufacturers could use to have their products tested to comply with their regulatory obligations.

On the subject of phthalates, one such standard is BS EN 14372 – Child use and care articles. Cutlery and feeding utensils. Safety requirements and tests.

It specifies safety requirements for products which are made for children aged up to 36 months to enable them to eat food by themselves or with help from another person.

For such products that are designed as a toy or with features that resemble a toy, then you may have to meet the requirements of EN 71.

Phthalate Lab Testing

To reiterate, phthalates are increasingly being regulated across multiple jurisdictions, and this will affect importers and manufacturers. Thus, testing for compliance is vital.

Here are a few lab testing companies that offer testing services for phthalates:

• Intertek
• QIMA
• Eurofins
• SGS