Tooth whitening

Tooth whitening

Historically, the legal position in Europe relating to Contents

tooth whitening has been confusing, with different
interpretations of the EU Directive being applied in 3 Legal levels of hydrogen peroxide
different countries. In the UK a House of Lords judgement
in June 2001 confirmed that tooth whitening products 3 Supply and use
were covered by the EU Cosmetics Directive and not the
Medical Devices Directive. 4 Penalties

The BDA, through the Council of European Dentists 4 Whitening technique

(CED), has been lobbying the European Commission to
remove all legal restrictions on dentists so they can carry 4 Unmarked products
out procedures in line with accepted clinical practice.
Following extensive lobbying, the EU Cosmetics Directive 4 Who can carry out tooth whitening?
was finally amended in 2011, as a result of this the UK
Cosmetic Product (Safety) (Amendment) Regulations
2012 came into force on 31st October.

The following guidance summarises the changes in the

UK regulations and provides the views of the General
Dental Council and the Department of Health. It amends
previous guidance issued by the BDA in November
2012 following receipt of new legal advice on the
interpretation of the regulations.

A BDA media kit has also been developed for members

to explain the benefits of whitening and provide advice
to patients on who can legally provide whitening
treatments. A dedicated web page for patients has also
been produced.

For bespoke 1-2-1 advice upgrade to Extra membership

call 020 7563 4550
© BDA June 2014

Legal levels of hydrogen peroxide
In December 2007 the opinion from the independent
EU Scientific Committee on Consumer Products (SCCP)
on the safety of tooth whitening products made it
clear that, for products between 0.1 and six per cent
hydrogen peroxide or equivalent, there must be a
clinical examination before tooth whitening takes place
and that the concentration and volume of the product
needs to be controlled.
On 31st October 2012 the concentration of hydrogen
peroxide legally permitted increased to six per cent in
line with the SCCP opinion. The new UK regulations
mean that:
• products containing or releasing over 0.1 per cent
hydrogen peroxide cannot be supplied directly to
the consumer
• products containing or releasing between 0.1 and
six per cent hydrogen peroxide can only be sold to
dental practitioners
• products containing or releasing between 0.1 and
six per cent hydrogen peroxide can only be made
available to patients following an examination
with the first episode of treatment being provided
by a dentist, or by a hygienist or therapist under
supervision of a dentist (i.e. within the same dental
setting) after which they can be supplied to the
patient to complete the cycle of use.
• products containing or releasing over 0.1per cent
cannot be supplied to persons under 18 years of age
• it is illegal to supply any product containing or
releasing over six per cent hydrogen peroxide.
Carbamide peroxide based whitening products are
covered by the regulations as they release hydrogen
peroxide when applied. Products containing 10%
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carbamide peroxide will release approximately 3.6
per cent hydrogen peroxide. Therefore approximately
16.62% carbamide peroxide will release hydrogen
peroxide at the legal limit of 6per cent. These levels
should be taken into account when selecting suitable
carbamide peroxide based whitening products.
Product manufacturers should be able to provide
confirmation of the amount of hydrogen peroxide
released from the products they supply.
Sodium perborate based whitening products are also
covered by the regulations as they too release hydrogen
peroxide when applied. However, these products should
not be used due to serious patient safety concerns. The
European Commission have classified sodium perborate
as toxic to reproduction, category 2. A substance
classified as toxic to reproduction category 2, means that
the substance is suspected to be a human reproductive
toxicant, and there is some evidence from humans or
experimental animals of an adverse effect on sexual
function and fertility or on development of the offspring.
Under EU legislation any substance classified as
carcinogenic, mutagenic or toxic to reproduction,
categories 1 and 2 which could also be used by
consumers is to be banned from manufacturing,
placing on the market and use. As a consequence
the Commission is working on a proposal to ban this
substance for consumer uses. There are also serious
concerns regarding the safety of chlorine dioxide based
whitening products; these whitening agents should not
be used.
The BDA will monitor any advances in the evidence
base for the use of products containing or releasing
over six per cent hydrogen peroxide and campaign for
legislative changes that reflect this.
For bespoke 1-2-1 advice upgrade to Extra membership - call 020 7563 4550
Tooth whitening
The CED made a commitment to annually report to the
European Commission the occurrence of undesirable
effects caused by tooth whitening products containing
between 0.1 and six per cent of hydrogen peroxide or
between 0.3 and 16.62% of carbamide peroxide which
have been observed by dentists or reported by patients
themselves to the dentist. The first report will comprise the
period from 31st October 2012 to 31st October 2013. BDA
members are encouraged to make such reports directly to
CED by completing the following questionnaire online.
Supply and use
The Department of Business, Innovation & Skills (BIS),
which oversees consumer safety and trading standards,
told the BDA that in its view the Consumer Protection Act
1987 and the Cosmetic Products (Safety) (Amendment)
Regulations 2012 do not cover the final ‘use’ of the
product; it advised that these specific regulations do not
prevent the direct application of any whitening product
of any concentration to the teeth. This view suggests that
enforcement action by a local trading standards authority
in relation to in-surgery whitening is currently unlikely,
regardless of the patient’s age or the concentration of
product used. However, until formal guidance on its
enforcement approach is issued it would be appropriate
to remain cautious when considering this risk.
It is important to note that the interpretation of the
regulations by BIS is not widely shared. Legal advice
received by the BDA shows that BIS’s view on final use
is incorrect. Dental Protection Ltd, The Dental Defence
Union and the General Dental Council (GDC) have also
received legal opinions that contradict the BIS view. The
legal advice is clear that the ‘use’ of a teeth whitening
product on a patient in the surgery does constitute a
‘supply’ of that product, and therefore the six per cent
limit is applicable.
© BDA June 2014

The GDC does not bring criminal prosecutions for
breaches of the cosmetic regulations; however it is
concerned with the fitness to practise of its registrants.
It takes the view that if a registrant has, in its opinion,
committed a criminal offence, that must be relevant to
any assessment of that registrant’s fitness to practise
irrespective of whether there has been a prosecution.
Therefore, if the GDC receive information or a complaint
that a registrant is using a product for cosmetic
purposes in excess of the six per cent the registrant may
face fitness to practise proceedings. The GDC’s position
statement is available in full here. This statement was
updated in May 2014 to reflect the GDC’s view that
products containing or releasing between 0.1 and six
per cent hydrogen peroxide can be used on any person
under 18 years of age where such use is intended
wholly for the purpose of treating or preventing
disease.’
Regardless of the current different legal interpretations,
products containing or releasing over six per cent
hydrogen peroxide will no longer be available from
reputable UK manufacturers or suppliers.
Penalties
The penalties for illegal supply are six months in prison,
a fine of £5,000 or both. Dentists must be aware that
it is up to each local Trading Standards Department to
decide if they wish take a prosecution. To date, only one
dentist in the UK has been prosecuted for breaching the
cosmetic regulations, with the dentist in question given
a conditional discharge and ordered to pay £1,795
in costs. It should be noted that this case was taken
before the change in the UK regulations when the legal
concentration of hydrogen peroxide based whitening
products was just 0.1 per cent.
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Whitening Technique
There is nothing illegal or unsafe about the technique
of tooth whitening, as confirmed by the Department
of Health in December 2006.The technique is in many
cases to be preferred to alternative treatments involving
the unnecessary removal of healthy tooth structure. The
Department of Health have added that it ‘would not seek
to interfere with a dentist’s therapeutic decision to utilise a
bleaching technique’ where a dentist considers this to be in
the best interests of the patient’s overall oral health care.
Unmarked products
Following the House of Lords case, unmarked products
containing hydrogen peroxide levels above the
legal limit have been supplied to dentists without
instructions or indications so that dentists could in turn
supply the products to patients. Although untested in
relation to tooth whiteners, our legal advice is that if the
dentist’s intended purpose for the product is for tooth
whitening use, the use is still covered by the Cosmetics
Regulations. Our legal advice supports the view that it is
the product’s intended purpose [intended by the person
supplying the product to the patient] which determines
its classification, not the method or area of application.
For bespoke 1-2-1 advice upgrade to Extra membership - call 020 7563 4550
Tooth whitening
Who can carry out tooth whitening?
It is the GDC view that applying materials and carrying
out procedures designed to improve the aesthetic
appearance of teeth amounts to the practice of dentistry,
as governed by the Dentists Act 1984. This view was
confirmed by the High Court in May 2013. Anyone who
practises dentistry illegally risks being prosecuted by
the GDC in the criminal courts. Dental hygienists and
dental therapists can carry out tooth whitening on
the prescription of a dentist if they have the necessary
additional skills. The taking of impressions to a dentist’s
prescription and making bleaching trays to a dentist’s
prescription are within the scope of additional skills for
dental nurses.
The GDC have prosecuted a number of individuals for
the illegal practice of dentistry following complaints
from members of the public and dental professionals.
To report someone illegally practising dentistry email
illegalpractice@gdc-uk.org or contact the GDC’s Illegal
Practice Team by calling 0845 222 4141.
To report a breach of the UK cosmetic regulations in
relation to the supply of hydrogen peroxide based
whitening products to non-dentists, or because the first
application of a hydrogen peroxide based whitening
product was by a non-dentist visit the Trading
Standards Institute to find details of the nearest Local
Authority Trading Standards Department.
If you wish to discuss this issue further please contact
BDA’s Health and Safety Team on 0207 563 4572.
© BDA June 2014