PLEASE
PRINT THIS PAGE FOR YOUR REFERENCE.
If
you'd like to view a version of the official guide, click
this link
If
you'd like to view the Trading Standards
advice booklet, click
this link
Because
current EU legislation and the requirement for safety assessments
on cosmetic products has now been in existance for several years
we have taken the opportunity to completely revise our website
advice. We now also provide various solutions to our customer's
problems of having their own finished products properly and legally
assessed so as they can be legally sold within th EU. We can provide
our customers with various levels of assistance as follows...
1.
Pre-assessed
product which does not therefore require further safety assessment,
nor does it require the customer to keep their own Product Information
File, but product should be batch labelled with the batch codes
we supply with the product for traceability.
2.
Affordable,
limited, safety assessment packages developed in conjunction
with experienced industry consultants which allow the small business/crafter
to produce entirely bespoke finished products using various sized
'packages' at fixed prices using product sourced exclusively from
ourselves, or with a supplement, to include product sourced from
other recognised UK stockists. Packages can be affordably added
to within certain restrictions, allowing a product range to grow
and develop without the need for complete re-assessment at a later
stage.
3.
Affordable
Comprehensive safety assessment packages based on a wider
range of bases and materials available from most recognised UK
suppliers which allows the more adventurous individual/small business
the opportunity to work with a wider-ranging selection of ingredients
that are commonly used in many soap, toiletry and cosmetic products
and to produce genuinely individual product ranges. Again, these
packages can be added to as product ranges grow and evolve.
4.
Bespoke
assessments which can also include assistance in product formulation,
challenge and stability testing, technical advice and ongoing
product support which is handled directly from our retained consultants.
We
realise that the subject and content of safety assessment packages
is not a familiarity to many of our customers. We have tried to
lay out our package purchases on our shopping site in an understandable
and simple manner, but for your guidance we have prepared the
following separate
advice page.
For
those of you reading this page for it's informational content
about compliance with legislation, we have given below a basic
summary of how to comply with legislation as it currently stands
and what it requires you, as the manufacurer of your own products
to be doing, in order to be able to legally sell your products
within EU member states.
The
manufacturer (you) should prepare a Product Information File (PIF)
which should contain all information regarding manufacturing method,
ingredients, MSDS for all ingredients, allergen information, labelling
detail, batch records and traceability. This file should be kept
available for viewing by anyone requesting so.
Batches...
Each 'batch' of product should be issued with a batch number and
have full ingredients and origin of ingredients record written
and kept for scrutiny if required. Batch numbers should appear
on any product labelling to ensure it can be accurately linked
to the batch information for traceability purposes.
Labelling...
all product labelling should comply with INCI legislation, which
states that the INCI names for ingredients should be clear and
legible either on the product itself, or where not appropriate,
maybe because of size or where a product is offered unwrapped,
should be clearly visible at the point of display or on any over-packaging
such as outer boxes or wrap. Ingredients should use approved INCI
names for each one. Ingredients should be listed in descending
order of weight as they are included in the manufacture of the
product and should use the INCI names for each ingredient used.
For a guide to INCI terminology
for common ingredients, click this link.
Natural
Soaps... for a naturally saponified soap, which would have oils
and lye in manufacture, but would then not have any significant
amounts of either oils nor lye remaining in the final product,
the 'soap' ingredients are listed in approved terminology relating
to the finished substances. E.G. Soap made from Olive Oil and
Lye would be listed as 'Sodium Olivate'. There is no need to refer
to oils as their INCI names nor to Lye (Sodium Hydroxide), as
it is not present in the finished soap.
Ingredients
of 1% or less concentration can appear in any order at the end
of the ingredients list usually with the colour last..
Allergens
(sensitisers)... certain allergens present in many essential oils
and fragrance oils must be included in the INCI labelling in cases
where they exceed 0.01% in rinse-off products (soaps, shampoos
etc.) and in 0.001% in leave-on products (moisturising creams
etc.). Separate specific advice for this is available by clicking
this link.
Product
labelling should also include a 'point of contact' address for
the manufacturer (you). See
our guide..
As well
as the PIF and Labelling issues, there is a legal requirement
for the manufacturer (you) to hold a safety assessment for the
products you are selling if selling within the EU. A safety assessment
should be carried out by a 'competant' person and in choosing
this person or organisation you should ensure that they are experienced
in all aspects of the products you intend to sell and that they
are backed-up by their own Professional Indemnity Insurance, which
will be your protection financially if there should be any litigation
brought against you should anyone experience an adverse reaction
to any of your products.
Once
completed, your assessment is valid forever. It does not require
annual renewal.
You
should also notify the Department for Business, Enterprise and
Regulatory Reform (BERR), formerly the DTI, to advise them prior
to putting your products on the market. http://www.berr.gov.uk/files/file45185.pdf
The
DTI and Trading Standards can provide fuller information on the
legislation and how to comply. Their services are FREE and their
specific advice on labelling can be very useful.
Information
on the listing of allergens in finished products is available
here.
Useful
PDF list giving INCI names for common ingredients, here.
THESE
GUIDELINES ARE BASED UPON OUR OWN EXPERIENCES AND UNDERSTANDING
OF THE LAW AS IT STANDS IN THE U.K.
Safety
Assessment Packages and Services
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