# REACH Annex XVII Restrictions

Nonylphenol and its ethoxylates

Guidance Note

December 2010

Version 2.01 

## Safer business, heal thier environment

Managing dangerous substances -

A guide



## About this information pack

This guidance pack is about restrictions on the supply and use of nonylphenol and its ethoxylates under the REACH Regulation. It is intended to be read by companies involved in the supply or use of chemicals and mixtures in Europe for the purposes of cleaning, textile and leather processing, agricultural teat dips, me talworking, pulp and paper manufacture, cosmetics and personal care products. This guidance has been produced by the Environment Agency’s Chemical Compliance Team.

In this pack, you will find:

 Legal guidance notes – what the Regulations say

 Information about the restrictions – full text of the relevant restrictions

 Technical guidance notes – information about nonylphenol and its ethoxylates

 Questions and answers – advice and guidance in response to common questions about the scope of the restrictions

 Contacting us – how to contact the Chemical Compliance Team

 Further information – Other useful contacts and resources

 Glossary of terms and abbreviations

If you need help and advice We have made these guidance notes as straightforward as possible, but please get in touch with us if you need any more advice about:

 potential sources and use of nonylphenol and its ethoxylates;

 the REACH restrictions relating to these chemicals.

Our contact details are provided on page 8 of this guidance document.

You may wish to seek legal advice or contact a relevant trade association.



## About the Environment Agency

Who are we & what do we do?

We are the Environment Agency. It’s our job to look after your environment and make it a better place – for you, and for future generations.

Your environment is the air you breathe, the water you drink and the ground you walk on. Working with business, Government and society as a whole, we are making your environment

cleaner and healthier.

The Environment Agency. Out there, making your environment a better place.2 

## Legal guidance notes

We have prepared these guidance notes to help you understand restrictions on the supply and use of nonylphenol and its ethoxylates in Europe. The restrictions are contained in the Registration, Evaluation, Authorisation and restriction of Chemicals Regulation 2006 (As amended). This law is referred to in these notes as ‘ the REACH Regulation’ or ‘the Regulation’

. For information about the other requirements of the REACH Regulation, such as registration of chemicals, or authorisation, please contact the Health and Safety Executive (details on page 9).

Background The REACH Regulation 2006 (as amended) is an EU regul ation that is directly applicable in all European Union member states. Annex 17 of the Regulation contains a list of chemicals that are subject to restrictions. The restrictions control the supply and/or use of certain chemicals in concentrations equal to or exceeding the limits stated in the Regulation.

Environmental impact The chemicals restricted by the Regulation hav e been scientifically proven to pose significant risks to human health and the environment. They t end to be persistent, which means they don’t break down in the environment easily. They are often toxic to marine and freshwater life and can stay in water for a very long time. Please refer to the technical guidance notes to find out more about the chemical in question.

Legal requirements The law states that if your company has involvement with any article, substance, mixture or preparation containing a restricted chemical, and the concentration of the restricted chemical is equal to or greater than the limits specified in the Regulation, you must ensure that you do not place it on the market or use it except in accordance with the restrictions listed in Annex 17.

Article 3 of the Regulation includes the following definitions:

“Article” means an object which during its production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition;

“ Substance ” means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

“ Preparation ” means a mixture or solution composed of two or more substances;

“ Placing on the market ” means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market;

“ Import ” means the physical introduction into the customs territory of the Community.

“ Mixture ” is not defined in the Regulation, however it should be taken to mean any blend or

combination of chemicals that includes the substance referred to in the restriction.

The Environment Agency is one of the enforcing authorities for this Regulation. Under the REACH Enforcement Regulations 2008, we have the power to take appropriate enforcement action against non-compliance with REACH restrictions. We will enforce REACH proportionately, in line with our Enforcement and Sanctions Guidance (published on our website, or available upon request). Enforcement action may mean the issuing of enforcement notices, prohibition notices or prosecution. Prosecution may lead to a fine or imprisonment (or both).3 

## Information about the restrictions

Extract of REACH Regulation (EC) 552/2009 The full text of the REACH restrictions on nonylphenol and its ethoxylates is printed below. This information is correct at time of publication. Regulations are subject to change and you should check for amendments on a regular basis (see ‘Useful contacts and resources’ section on page 9 to find out how).

Annex XVII: Restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles.

Entry 46 - Restriction of nonylphenol and its ethoxylates

46. (a) Nonylphenol C 6 H 4 (OH)C 9 H 19 CAS 25154-52-3 EC 246-672-0 (b) Nonylphenol ethoxylates (C 2 H 4 O)

n C 15 H 24 O

Shall not be placed on the market, or used, as substances or in mixtures in concentrations equal to or greater than 0,1 % by weight for the following purposes:

(1) industrial and institutional cleaning except: — controlled closed dry cleaning systems w here the washing liquid is recycled or incinerated, — cleaning systems with special treatment where the washing liquid is recycled or

incinerated.

(2) domestic cleaning;

(3) textiles and leather processing except: — processing with no release into waste water, — systems with special treatment where the process water is pre-treated to remove the organic fraction completely prior to biological waste water treatment (degreasing of sheepskin);

(4) emulsifier in agricultural teat dips;

(5) metal working except: uses in controlled closed systems where the washing liquid is recycled or incinerated;

(6) manufacturing of pulp and paper;

(7) cosmetic products;

(8) other personal care products except: — spermicides;

(9) co-formulants in pesticides and biocides. However national authorisations for pesticides or biocidal products containing nonylphenol ethoxylates as co-formulant, granted before 17 July 2003, shall not be affected by this restriction until their date of expiry.4 

## Technical guidance notes

This technical guidance relates to the chemical nonylphenol and its ethoxylates (hereafter referred to as NP and NPE). These notes should help you to find out if the restricted chemical is present in any of the substances or mixtures that your company supplies or uses in Europe.

What are NP and NPE? Nonylphenol (NP) is a man-made organic compound with the chemical formula C 6 H 4 (OH)C 9 H 19

. Neat NP is a viscous (thick and sticky) liquid with a clear to yellow appearance.

Nonylphenol ethoxylates (NPE) are man-made compounds with the chemical formula (C 2 H 4 O)

n C 15 H 24 O. They are compounds of nonylphenol [C 15 H 24 O] with one or more groups of ethoxylates [(C 2 H 4 O)

n ] attached. The number (

n ) of ethoxylate groups varies between NPE compounds, imparting different properties to the chemical substance. Neat NPEs may be viscous liquids, becoming waxy solids when more ethoxylate groups are added. They are generally clear to light amber in appearance.

Use of NP and NPE NP is primarily used in the production of NPEs. It may also be used to produce products such as plastics stabilisers, and phenol-, formaldehyde- and epoxy resins.

NPEs belong to a group of chemicals called alky lphenol ethoxylates (APEs); they are non-ionic surfactants. The wetting properties of NPEs lend themselves particularly well to degreasing activities, whilst their dispersant properties m ean that they may also be used where chemical formulations need to be distributed evenly within a product or throughout a component. Hence, NPE has been used in cleaning products, paints, ink dispersants, textile and leather processing, manufacture of pulp and paper, metalworking, cosmetics and personal care products. NP and NPE are able to affect the cells of living organisms and have been used in pesticides, production of certain medicines and as spermicides.

Many of these applications are now restricted.

NP and NPE in the environment The presence of NP in the environment is largely a result of the break down of NPEs. NP poses particular risks to the aquatic environment and is a ‘priority hazardous substance’ under the Water Framework Directive. NP and NPE continue to be detected in water quality monitoring.

Ethoxylate groups degrade slowly and NPEs containing more ethoxylate groups may not be broken down entirely during wastewater treatment. In any case, the NP group is particularly stable and can remain intact throughout normal wastewater processing. Data from the Environment Agency’s Pollution Inventory shows that both NP and NPEs continue to be discharged from wastewater treatment works in England and Wales.

These chemicals have a tendency to accumulate in the tissues of plants and animals – this may be the result of direct environmental exposure or from consuming contaminated food or fluids. NP has also been shown to act as an ‘endocrine disruptor’ in living organisms, meaning that it has the potential to mimic hormones – in this case, oestrogen. Therefore, exposure to NP may interfere with breeding patterns and the reproductive success of animals.

Research has demonstrated that the chemicals can cause harm to land-dwelling organisms. Toxicity tests of NP on plants show effects on growth, while tests on invertebrates have resulted in impacts on reproduction and mortality.5 Are you supplying or using substances or preparations for a restricted purpose? If a substance or mixture has a NP or NPE concentration of 0.1 % by weight or more, then your company should not supply it or use it in Europe except in accordance with the restrictions. The full text of the restrictions on NP and NPE is supplied on page 3 of this guidance note (extracted from Annex 17 of the REACH Regulation 2006 [as amended]).

If you are supplying any substance or mixture whic h contains NP or NPE at a concentration of

0.1 % by weight or more, you must check all your promotional materials to make sure that you are not advertising or endorsing it to be used for any of the restricted purposes. You should review your packaging, labelling, catalogues, mail shots and flyers, internet promotions and any other marketing materials to make sure that you are compliant with the Regulation.

It is good environmental practice to highlight the restrictions to your customers so that they can ensure their own compliance with the law. You should not supply products containing 0.1% or more of NP or NPE to any co mpany whom you know will be using it for a restricted purpose (except as described below).

When supplying metalworking, textile and leather processing products that contain 0.1% or more of NP or NPE, it would be diligent to highlight the necessary closed-systems and water treatment requirements to your customers.

How to determine NP or NPE concentration There are a number of ways to find out whether a substance or preparation you use contains NP or NPE and, if so, what the concentration is.

 Check the label on the packaging of the substance/preparation and also the Safety Data Sheet (SDS) from your supplier. Please note that the labelling and SDS may not specify NP or NPE, it may give a Chemical Abstract Service (CAS) or European Commission (EC) number or state a synonym.

Nonylphenol One of the following chemical identification numbers should be present:

o CAS registry number: 25154-52-3

o EC number: 246-672-0

Nonylphenol ethoxylates NPE may be generically listed as a ‘non-ionic surfactant’ but a CAS or EC number should also be present. Below are some examples of synonyms for NPE and CAS numbers, please

be aware that this list is not exhaustive:

o nonoxynol,

o ethononylphenol,

o polyoxyethylene nonylphenol ether

o nonylphenoxypoly (ethyleneoxy) ethanol

o Nonylphenol, branched, ethoxylated

o CAS 26027-38-3

o CAS 9016-45-9

o CAS 104-40-5

o CAS 127087-87-0

o CAS 68412-54-4

If you have a CAS or EC number and need to find out what substance it is referring to, you can use the European chemical Substances Info rmation System (ESIS) website (details on page 9).

 Contact your supplier and ask them directly.6  If you are unable to find out by other means, you can send a sample for laboratory analysis. No specific method is listed in the restriction. When choosing a laboratory to carry out the analysis, you should check that they have an accredited method that will detect up to 20 ethoxylate groups.

What to do about non-compliant products If you identify a product that is not compliant with the restrictions on NP and NPE, you must cease to supply or use it anywhere in Europe with immediate effect. The product should be returned to the supplier or disposed of as waste (see ‘Waste management’ guidance, below).

Companies undertaking metalworking, or textiles and leather processing If you are using substances or mixtures that contai n 0.1% by weight or more of NP or NPE, you must make sure that the operation meets any legal requirements regarding closed systems, biological treatment and/or recycling/incineration of the wastewater at all times . If the system

fails and you cannot meet the requirements , you must cease operation until the necessary maintenance has been carried out to remedy the situation.

Reporting non-compliance You can inform us about suspected non-compliance with the restrictions on NP and NPE by using the contact details on page 8 of this guidance.

Alternatively, you can give us the details via our non-compliance hotline. This is an answering machine service. Messages can be left anonymously if you prefer, although supplying your own contact details may help us to investigate the matter.

Non-compliance hotline: 0800 023 2090

Waste management If you want to dispose of substances or preparations that contain NP or NPE, you will need to have them removed by a registered waste carrier to a permitted waste disposal site. Please be aware that we do not endorse any particular disposal process or disposal contractor.

Under duty of care , you have a legal obligation as a holder of waste to arrange for it to be disposed of properly. You may also need to carryout a hazardous waste assessment because there are particular requirements for how hazardous waste must be stored, transported and disposed of.

You must make sure that anybody who offers to:

 transport waste – holds a waste carriers registration

 move hazardous waste – uses a consignment note

 dispose of waste – holds an appropriate environmental permit.

Please note: Waste chemicals should always be handled according to the advice on the Safety Data Sheet.

If you dispose of hazardous waste in quantities of more than 500kg in a year then you need to register as a hazardous waste producer.

For more information you can:

 visit our website: www.environment-agency.gov.uk – search for ‘hazardous waste’

 call our National Customer Contact Centre on 08708 506 5067 Questions and Answers

Some of the questions we have received about the scope of the restrictions on nonylphenol and its ethoxylates are answered below. If you have a ques tion that is not covered by this guidance you can contact us (details on page 8); or you may wish to contact a relevant trade association or seek legal advice.

What is covered by the term ‘cosmetic product’?

The term ‘ cosmetic product ’ means any product that meets the definition provided by the Cosmetics Directive 76/768/EEC (as amended), as follows:

‘ Any substance or mixture intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition. ’

How do the restrictions under REACH differ from those under the Cosmetics Directive? Restriction of cosmetics formulations for protection of human health is not within the scope of the REACH Regulation. The cosmetics restrictions contained in Annex 17 of REACH are for the purposes of environmental protection

.

The Cosmetics Directive allows for the presence of traces of nonylphenol and its ethoxylates in cosmetic products, provided that the concentration is ‘technically unavoidable’ in good manufacturing practice and that the product does not cause harm to human health

.

REACH states a specific concentration limit. U nder the REACH Regulation, any substance or mixture that contains 0.1% by weight or more of NP or NPE cannot be placed on the market or used for the purpose of a cosmetic product within the EU.

Please note: A cosmetic product that complies with the restrictions on NP and NPE under the REACH Regulation does not necessarily comply with the Cosmetics Directive; this is because a lower concentration may be achievable in good manufacturing practice.

The requirements of the EU Cosmetics Directive are implemented into UK law by the Cosmetic Product (Safety) Regulations 2008 (as amended). If you would like to know more about the safety regulations for cosmetics products, visit the Department for Business Innovation and Skills (BIS) website at www.bis.gov.uk and search for ‘cosmetics’.

Do the restrictions apply to concentrated products that are intended to be diluted? Concentrates containing NP or NPE at 0.1% by weight or more are also covered by the restriction, even if the recommended dilution would reduce the NP or NPE concentration in the resultant mixture to less than 0.1% by weight.

What about treated textiles imported from outside of the EU?The REACH restrictions on NP and NPE do not cover the placing on the market or use of pretreated goods imported from outside of the EU. However, in the interests of environmental protection we would encourage companies in England and Wales to avoid the import of such products wherever feasible.8 

## Contacting us

If you need to contact us, please do so by one of the following methods:

Send an email to chemicalrestrictions@environment-agency.gov.uk This inbox is checked daily and, in line with our Customer Charter, you can expect a response to your enquiry within 10 working days.

Call our National Customer Contact Centre (NCCC) Telephone 08708 506 506 and ask to speak to a member of the Chemical Compliance Team

about REACH

.

Write a letter to: The Chemical Compliance Team Waste and Industry Regulatory Service The Environment Agency
Quadrant 2 99 Parkway Avenue

Sheffield

S9 4WF9 

## Further information

The Health and Safety Executive (HSE) hosts the UK Competent Authority for the REACH Regulation and has produced a broad range of guidance notes. If you want to know more about the Regulation and how it may affect your business please go to www.hse.gov.uk/reach or send

an email to UKREACHCA@hse.gsi.gov.uk

The European Chemicals Agency (ECHA) administers the REACH Regulation across Europe. ECHA has produced detailed guidance about the different aspects of the Regulation, which are published on its website at http://echa.europa.eu/home_en.asp

To check the chemical name for any CAS or EC number, go to the European chemical Substance Information System (ESIS) website at: http://ecb.jrc.ec.europa.eu/esis/

Information about the safety regulation of cosmet ic products in the UK is available from the Department for Business Innovation and Skills (BIS). Visit their website at www.bis.gov.uk

and search for ‘cosmetics’.

Copies of the REACH Regulations

The following publications are also available:

 The Registration, Evaluation, Authorisation and restriction of Chemicals Regulation 2006 (as amended)

This publication and its amendments are available online from: http://eur-lex.europa.eu/en/index.htm

 The REACH Enforcement Regulations 2008 No.2852

This publication is available free of charge online from: www.statutelaw.gov.uk or you can order copies by post (fees apply) from:

The Stationery Office Ltd, TSO Customer Services, P.O. Box 29,
Norwich,

NR3 1GN.

Tel. 0870 600 5522.

Please Note:

Regulations are subject to amendments.

 The REACH Annex 17 restrictions are contained in Commission Regulation (EC) No

552/2009 ;

 Annex 17 has been amended by Commission Regulation (EU) No 276/2010 (this

amendment does not affect the restrictions on nonylphenol and its ethoxylates);

 Offences, enforcement powers and penalties are contained in the REACH Enforcement Regulations 2008 (No.2852)

This information is correct at the time of going to print.10 

## Glossary of terms and abbreviations

The following definitions are provided for your information. If you require further assistance, please contact us using the details on page 8 of this document.

Annex XVII – Annex 17 of the REACH regulation, contains a list of chemicals and the restrictions on their supply and use.

CAS registry number – Chemical Abstracts Service registry number. CAS is a division of the American Chemical Society. Registry number s are unique identification numbers given to

chemical substances.

Competent Authority – a designated authority or organisation that is responsible for administration of a regulatory regime within the country’s boarders.

Cosmetic product – a product as defined by the Cosmetics Directive 76/768/EEC (as amended). The full definition is supplied on page 7.

Duty of care – as regards to waste, duty of care is the legal responsibility on any holder of waste to make sure that it is handled and disposed of correctly, and that it can be traced from the producer of the waste to its disposal destination (cradle to grave).

EC number – European Commission number. Chemicals that are available in the EC are listed on the EC Inventory and have a unique 7 digit identif ication number with the format xxx-xxx-x. The EC Inventory collates the 7 digit numbers from other European chemicals inventories, including the European Inventory of Existing Commercial Chemical Substances ( EINECS number), European List of Notified Chemical Substances ( ELINCS number), and the No-Longer Polymers list ( NLP number).

ECHA – the European Chemicals Agency is an Agency of the European Union. It ensures the consistent implementation of the REACH Regulation across Europe.

Hazardous waste – a waste that is harmful to the environment, or to human health. It may be hazardous immediately or over an extended period of time. In European law, a hazardous waste is a type of waste material that is marked with an asterisk on the European Waste Catalogue and presents one or more of 14 hazard types listed in the Hazardous waste

Directive.

HSE – the Health and Safety Executive, which hosts the UK REACH Competent Authority.

Non-ionic surfactant – a surfactant that does not have a positive or negative charge (is neutral).

NP – Nonylphenol.

NPE – Nonylphenol ethoxylates.

REACH – The European Registration, Evaluation, Authorisation and restriction of Chemicals Regulation (EC) 1907/2006 (as amended).

Surfactant – another name for ‘surface active agent’: a natural or synthetic substance that promotes the mixing of oil and water.

Synonym

– different names for a chemical, may include abbreviations or trade names for specific formulations.