Henna Hair and Skin Product Safety Report Paul Leighton

Henna Hair and Skin Product Safety Report
Paul Leighton
Trading Standards Enforcement Officer
Henna Hair and Skin Product Safety Report
Contents
Page
1. Introduction
3
2. Extent of the Problem
4-5
3. Methodology
6
4. Findings
7-8
5. Action Taken
9
6. Conclusions
10
Test Report
Appendix 1
2
Introduction
The purpose of the safety report was to assess the range of henna hair and skin products
available from business premises in Newcastle upon Tyne, for compliance with the
requirements of the Cosmetic Product (Safety) Regulations 2008 (CPSR).
The CPSR applies to any products which are intended to be placed into contact with,
amongst others, the skin and hair system, for the purpose of keeping in good condition or
to change its appearance. The only exemption to this is the prevention or treatment of
disease. As such, henna hair and skin products fall within the scope of the legislation.
The formal sampling of henna products would look at all aspects of the CPSR, including
chemical composition, labeling, and misleading claims.
3
Extent of the Problem
West Yorkshire Trading Standards Service (WYTSS) undertook a market surveillance
project in August 2012 to examine the same issues in their authority. The results of the
market surveillance found that of 80% of samples received adverse comments from the
analyst, with only 14 of the 70 samples being found to be fully compliant.
Although Newcastle City Council Trading Standards Service (NCCTSS) has not received
any complaints about henna products in the region, the WYTSS project was initiated after
a complaint received in June 2012 about a henna product available in the region which
caused burning and itching when applied to skin.
This Trading Standards Service is aware of the issues with the composition of haircolouring products after a brand known as Kala Kola was found to contain lead acetate
which is prohibited under the CPSR. The product was widely available at shops throughout
the area, and a series of premises visits results in large volumes of the product being
seized and destroyed.
Internet-based research demonstrates widespread acknowledgement that there is an issue
with unsafe henna products. In particular there are a large number of journal articles
relating to people, especially children, who have had henna tattoos and artwork applied by
street vendors when on holiday abroad, which have caused ‘burns’ on the area of skin
where the henna has been applied.
The typical cause of this reaction is because the artist has used a mixture of hair dye,
which would be composed of the chemical para-phenylenediamine (PPD), and PPD
creates a darker tattoo. Natural henna would leave an orange or brown tattoo.
Under the CPSR, PPD is only permitted, at certain levels, for use in hair dyes, and
prescribed warnings must be placed on the product or packaging alerting consumers to its
sensitizing effects.
There is no suggestion that when used properly, natural henna in its proper form creates
any risks to the user.
4
The Rapid Alert System for Non-Food Products (RAPEX) is the EU’s information exchange
database for alerting other enforcement authorities of dangerous products that have been
found on, or entering the market. Consumers and business have access to these reports.
A search of RAPEX provides 18 separate reports of dangerous henna products that have
been discovered within the EU since 2005. The majority of reports are for non-compliance
with the Cosmetics Directive 76/768/EEC, which resulted in the CPSR. All of the reports
were made because of issues with the chemical composition of the product, and all
measures taken were the seizure and destruction of the product.
Taking into account the findings from WYTSS, our previous experience with hair-colouring
products, the online research, and RAPEX alerts, we believed there was adequate
justification to carry out a project to examine the safety of henna hair and skin products
available within Newcastle upon Tyne.
5
Methodology
In November 2012, Officers from NCCTSS conducted market surveillance in order to
identify retailers throughout the city that were selling henna hair and skin products. Officers
carried out visual examinations of the products in order to ascertain basic levels of
compliance with the CPSR, such as labeling requirements.
Officers then returned to the retailers to carry out test purchases. Retailers were informed
of the reasons for the test purchase, and were provided with written explanation for the
safety project, and where possible, products which were already found to be in
contravention of the CPSR were identified and the business owners informed. A business
advice pack on the requirements of the CPSR was also provided to retailers.
Over 30 business premises were visited, and 13 individual henna hair and skin products
were identified and purchased from retailers. These were processed in accordance with
the requirements of the CPSR, which meant where possible, products were taken from the
same batch, remained unopened, and were placed in a sealed bag and exhibit label details
were completed.
We notified all premises visited that follow up visits would be conducted when the products
had been formally sampled, in order to advise of products that may be deemed unsafe.
WYTSS had used the public analyst at West York Analytical Services (WYAS). Prior to
conducting the test purchases it was agreed that we would use the same analyst because
of the familiarity with the testing of henna hair and skin products against the requirements
of CPSR, and an agreement was entered into with the test house.
The analyst would report back with details of the chemical composition of the products,
their specific levels, and any other concerns they had that would affect the compliance of
the product with the legislation.
6
Findings
Thirteen individual henna hair and skin products were sampled and tested by West
Yorkshire Analytical Services.
Henna hair and skin products were typically found to be available in the following
composition; dry powder that was to be mixed by the user for either a hair colorant or to
decorate the skin, a pre-mixed formula that came within an applicator for ease of use,
predominantly used to decorate the skin, or a liquid formula within a bottle, typically used to
colour the hair.
54% (7) of the samples received were found to be in contravention of the CPSR.
Features of the failures, as commented on by the analyst, include the following;
“The product was not marked with an ingredients list as required by the above regulations.”
“The
ingredients
included
rosha
list
oil,
nilgiri oil, water and
henna…. The sample
was found to contain
none
of
the
above
compounds
which
suggest that it contains
neither
of
declared.”
the
oils
Sanam
Special Dulhan Henna,
pictured right.
“The labelling did include an ingredients list… however in my opinion, the labelling is likely
to mislead consumers into thinking that the dyeing action of the product is due to the henna
ingredient alone.”
7
“The labelling of this product included the words ‘Afrin Nikhar Mehandi is natural mehandi’
and ‘pure herbal’. The sample was found to contain the chemical p-phenylenediamine. pphenylenediamine is a chemical dye and its presence is not consistent with the above
claims.”
“The Regulations require products containing p-phenylenediamine to be marked with
prescribed warnings. The warnings were not included in the labelling of this product.”
Although there were no issues identified such as the presence of prohibited chemicals, or
excessive levels of permitted chemicals, it was still a concern to note that in many
instances PPD was identified in products which claimed to be natural, misleading the
consumer, and the risks associated with using products that do contain PPD were not
present on the product or packaging as required under the legislation.
Other
labeling-related
problems
included a lack of; Name and
address,
Durability
indication,
Ingredients list, Batch number, or
Function of the product. None of
these appeared on the packaging
for Singar Special Mehndi, pictured
left, and are required to be stated in
English, under the CPSR.
A copy of the findings from the
WYAS test house is appended to
this report.
8
Action Taken
A business advice letter was made detailing the findings of WYAS, and this letter
specifically highlighted particular products that had failed to comply with the requirements
of the CPSR.
Information included with the letter details the name and manufacturer of the product, the
importer if these details were know, the reason for the failure, in addition to an image of the
sample itself to help retailers identify unsafe henna products.
Officers then revisited all premises that were originally identified as selling henna hair and
skin products, and a copy of the business advice letter was provided to all retailers. Help
was offered to identify offending products found on the shelves, and businesses were
asked to remove those found from sale, and to return them to distributors or suppliers.
Where possible, details of UK-based importers and suppliers were taken and a series of
home authority referrals were made, providing the local trading standards service with
details of the non-compliant product, the supplier in their area, and the reasons for the
failure.
Retailers were advised that should further premises inspections uncover continued sales of
non-compliant products, especially in instances where they have been specifically advised
against such sales of identified products, may result in the seizure of all stock, and the
consideration of legal proceedings for offences on the CPSR.
We have updated the pages of our website relating to product safety and business advice
to reflect the findings of this report.
A press release will be issued highlighting the dangers of certain henna products, and this
will hopefully be picked up by the local media in order to educate and protect consumers.
9
Conclusions
The work conducted by WYTSS suggested it was likely that we would find examples of
non-compliance in this authority, which we did. Our findings did not restrict the issue of
unsafe henna to black/dark henna, as there was an example of ‘brown’ henna also failing
to meet the requirements. We would suggest that the problem with non-compliant henna
hair and skin products is still a contemporary issue, despite RAPEX alerts dating back to
2005, and the implementation of the CPSR in 2008.
The main concern with the products was information misleading consumers to suggest
products were natural when they were not because of the chemical content, and those that
did contain PPD failed to warn consumers about its risks. Furthermore, many of the
products were missing key information that would allow for the proper identification of the
product and its importer or manufacturer.
As dangerous henna products continue to find their way onto the market within England
and throughout the EU, it is essential that the public are educated as to how to identify
products which are likely to fall foul of the regulations. Indicators such as a lack of
ingredients, or period of durability should be reinforced as potential symptoms of an unsafe
product, and negate the need for formal sampling. This should be extended across all
products subject to the CPSR.
As presented in the WYTSS report, as the origin of the henna hair and skin products tend
to be from outside of the EU, importation routes need to be targeted to prevent unsafe
products from reaching the market.
Ongoing checks on henna hair and skin products will be made as part of routine
enforcement work when visiting premises to ensure compliance with the legislation, and to
assess whether this project has been effective at a local level.
Paul Leighton
March 2013
10
Appendix 1
West Yorkshire
Analytical Services
West Yorkshire Analytical Services
PO Box 11, Nepshaw Lane South, Morley, Leeds LS27 0UQ
Tel: 0113 383 7550 Fax: 0113 383 7551
Email: [email protected]
Internet Web Site: www.analyst.wyjs.org.uk
Dr. Duncan Campbell B.Sc., D.Phil., M.Chem.A., C.Chem.,
F.R.S.C., Registered Analytical Chemist,
Public Analyst and Agricultural Analyst
Report No: BB20024 / CMH
05 March 2013
P Leighton
Trading Standards Service
Newcastle City Council
Barras Bridge
Newcastle upon Tyne
NE1 8PB
Submitted By:
Order No:
Date Submitted:
Date Analysis Completed:
P Leighton
RSPP/TS/PSL
15 January 2013
05 March 2013
TEST REPORT
The following samples have been analysed for compliance with the Cosmetic Products (Safety) Regulations 2008
with results as under. They were found to be satisfactory with respect to the analysis performed, except where
indicated.
Sample
Number
Lab
reference
Sample
Description
Chemicals detected
PSL01
BB20024
Zubeda New Formula Henna
None found
Quantity
(% w/w)
The sample was found to contain terpineol as indicated in its ingredients list and is considered satisfactory
PSL02
BB20025
Afrin Dulham Moglai Mehndi
None found
The composition of the sample was found to be satisfactory. The durability indication was not given in the
prescribed form. The product was not marked with an ingredients list as required by the above Regulations.
PSL03
BB20026
Singar Special Mehndi
None found
The labelling of this product was missing the following information:
Name and address, Durability indication, Ingredients list, Batch number, Function of the product.
PSL04
BB20027
Afrin Nikhar Mehandi Hair
Paraphenylenediamine
2.5%
(PPD)
The labelling of this product was missing the following information:
Name and address
Ingredients list
The durability indication was not given in the prescribed form.
The labelling of this product included the words “Afrin Nikhar Mehandi is natural mehandi” and "pure herbal". The
sample was found to contain the chemical p-phenylenediamine. p-phenylenediamine is a chemical dye and its
presence is not consistent with the above claims. p-phenylenediamine is a chemical known to cause sensitisation
and its use by sensitised individuals can cause severe allergic reactions.
The Regulations require products containing p-phenylenediamine to be marked with prescribed warnings. The
warnings were not included in the labelling of this product.
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West Yorkshire Joint Services are provided by a Joint Committee of the Metropolitan Districts of
Bradford, Calderdale, Kirklees, Leeds and Wakefield.
Page 1 of 3
Sample
Number
PSL05
Lab
reference
BB20028
Sample
Description
Jani Kone Henna Paste
Chemicals detected
pH
Quantity
(% w/w)
4.5
The sample was found to contain terpineol as indicated in its ingredients list and is considered satisfactory
PSL06
BB20029
Sanam Special Dulhan Henna Cone Benzyl alcohol
The ingredients list included rosha oil, nilgiri oil, water and henna. Rosha oil is also known as palmarosa oil, a
naturally occurring plant extract containing myrcene, linalool, geraniol, geranyl acetate and limonene. Nilgiri oil is
also known as eucalyptus oil, a natural plant extract containing cineole. The sample was found to contain none of
the above compounds which suggests that it contains neither of the oils declared. The sample did contain benzyl
alcohol, a flavouring commonly used in cosmetic products, but it presence was not declared.
The labelling did not include the following information:
Name and address
Durability indication
Batch number
PSL07
BB20030
Palwasha Pure Henna
The labelling did not include the following information:
Durability indication
None found
PSL08
p-aminophenol
BB20031
Glory Brown Henna
5.2%
The labelling of this product was marked in several places with the words “brown henna” and, in my opinion, it is
likely to be taken by an intending purchaser that the product contains only henna. The sample was found to
contain the chemical dye p-aminophenol. The labelling did include an ingredients list which included “PPD” and "PAmino Phenol", however in my opinion, the labelling is likely to mislead consumers into thinking that the dyeing
action of the product is due to the henna ingredient alone.
PSL09
BB20032
A1 Products Zarqa Black Henna
The sample was found to be satisfactory
None found
PSL10
None found
BB20033
Black Dulhan Mehndi
The sample was found to be satisfactory
PSL11
BB20034
Saniya Hair Henna
Paraphenylenediamine
0.4%
(PPD)
The labelling of this product included the words “Saniya Mehandi is a natural mehandi”. The sample was found to
contain the chemical p-phenylenediamine. p-phenylenediamine is a chemical dye and its presence is not
consistent with the above claim. p-phenylenediamine is a chemical known to cause sensitisation and its use by
sensitised individuals can cause severe allergic reactions.
The Regulations require products containing p-phenylenediamine to be marked with prescribed warnings. The
warnings were not included in the labelling of this product.
PSL12
BB20035
Advanced Formula Kala Kola
Paraphenylenediamine
(PPD)
3.6%
The sample was found to be satisfactory
PSL13
BB20036
Zubeda Special Henna
None foumd
The sample was found to be satisfactory
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Labelling requirements from the Regulations
The Cosmetic Products (Safety) Regulations 2008 require that no person shall supply a cosmetic product unless
the container and packaging is marked with:
The name or style and the address or registered office of the manufacturer or the person responsible for marketing
the cosmetic product who is established within the EEA;
Where the cosmetic product is manufactured outside the EEA, the country of origin must also be specified.
The date of minimum durability - indicated by the words: ‘best used before the end of’ followed by either the date
itself, or details of where it appears on the packaging, clearly expressed and consisting of either the month and
year or the day, month and year in that order, except where the cosmetic product has a minimum durability of more
than 30 months, in which case it is not mandatory to indicate the date of durability, but such a product shall have an
indication of the period of time after opening for which the product can be used without any harm to the consumer.
This information shall be indicated by the prescribed symbol followed by the period in months or years or both
months and years;
Particular precautions to be observed in use as set out in the Schedules to the Regulations;
The batch number of manufacture or the reference for identifying the goods;
The function of the product, unless it is clear from the presentation of the product;
A list, preceded by the word ‘ingredients’ of the ingredients in descending order of weight as they are added;
An ingredient must be identified by the name provided for in the International Nomenclature of Cosmetic
Ingredients (INCI) or in the absence of such identification, by its chemical name, its European Pharmacopoeia
name, its International Non-proprietary name (INN) as recommended by the World Health Organisation, its
EINECS, ELINCS or CAS identification reference or its colour index number.
Perfume and aromatic compositions and their raw materials shall be referred to by the word ‘perfume’ or ‘aroma’.
The particulars referred to above shall be in English, but this shall not prohibit the additional use of other
languages.
If I can be of any further assistance regarding these results, please do not hesitate to contact me.
C M Hunt
B.Sc., M.Chem.A., C.Chem., F.R.S.C.
Public Analyst
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Direct Line: 0113 393 9718
Email: [email protected]
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