PIP
PRODUCT INFORMATION PACKAGE
Legal
requirements
The manufacture of cosmetics and toiletries is more regulated
than the food industry but not to the extent of the pharmaceutical industry.
The comparison between the production of pharmaceuticals in terms of GMP (Good
Manufacturing Practice) and the cosmetics and toiletries industry is not that
dissimilar.
1. In
2.
The EEC have Council Directive
76/768/EEC up to the 27th amending Directive 2003/15/EC and including the previous 26 amendments and
this has to be translated into the language of each member state, in the UK the
law is Statutory Instrument 2004 No. 2152 The Cosmetic Products (Safety) Regulations 2004 (107 pages)
3.
In addition, products must not infringe the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994, a very common
infringement with today’s eagerness to have ‘alluring’ pack copy. The
Regulations provide that, unless exempt, any “medicinal product” to which
Chapters II to V of Directive 2001/83/EEC apply must not be placed on the UK
market unless it has a marketing authorisation
(product licence) granted by the European Commission
or by the UK Licensing Authority. The Act similarly provides that, unless
exempt, any other “medicinal product” must not be sold or supplied without a
marketing authority. A marketing authorisation or
product licence is only granted for a product which
meets statutory standards of safety, quality and efficacy.
The
status of many products on the “borderline” between medicinal products and food
supplements, cosmetic or medical devices can be difficult to determine. The
MHRA have produced a Guidance Note 8 document to explain how and on what basis
the MCA decides whether products are medicines or not. It includes guidance on
the statutory procedures in Regulation 3A of the Regulations introduced by the
Medicines for Human Use (Marketing Authorisations
Etc.) Amendment Regulations 2000 (S.I. 2000/292).
4.
There is also the requirement to ensure that claims made on the packaging
comply with the Trade Descriptions Act 1968, Control of Misleading Advertising
Regulations 1988 (as amended)
5.
Products must also comply with the Weights and Measures Act 1985.
6.
Certain categories (e.g. insect repellants and products that contain this property)
may also be subject to the Statutory Instrument 2003 No. 429 The Biocidal Products (Amendment) Regulations
2003.
Compliance with these laws is mandatory in
Information
required
The Law says
Product Information
9. - (1) Subject to paragraph (8) below, where a
cosmetic product is manufactured or supplied in the United Kingdom a responsible
person shall for control purposes keep easily accessible to a United Kingdom
competent authority at the address or registered office specified on the
container or packaging of the cosmetic product in accordance with regulation
7(2)(a) above the following information -
(a) the qualitative and quantitative composition of the product, except to the extent that the
product is composed of any perfume or perfume composition, in which case the
responsible person shall only be required to keep the name and code number of
the perfume or perfume composition and the identity of the supplier;
(b) the
physico-chemical and microbiological specifications
of the raw materials and the finished product and the purity and
microbiological control criteria of the cosmetic product;
(c) the method of manufacture
which shall be in accordance with good manufacturing practice, that is to say
that the cosmetic product shall be manufactured in such a way that under normal
and reasonably foreseeable conditions of use it shall not endanger human health
or safety;
(d) an
assessment of the safety for human health of the finished product taking into
consideration the matters specified in paragraph (2) below;
(e) a specific assessment of
the safety for human health of the finished product taking into consideration
the matters specified in paragraph (2) below in respect of cosmetic products
intended for use on children under the age of 3 and for cosmetic products
intended exclusively for use in external intimate hygiene;
(f) the name and address of
the person or persons, qualified in accordance with paragraph (5) below,
responsible for the assessments referred to in sub-paragraphs (d) and (e)
above;
(g) existing
data on undesirable effects on human health resulting from use of the cosmetic
product;
(h) proof
of the effect claimed for the cosmetic product, where justified by the nature
of the effect or product; and
(i)
data on any animal testing performed by the manufacturer, his agents or
suppliers, relating to the development or safety evaluation of the product or
its ingredients, including any animal testing performed to meet the legislative
or regulatory requirements of countries which are not Member States;
(2) The assessments referred
to in paragraphs (1)(d) and (1)(e) above shall be
carried out in accordance with the principles of good laboratory practice
referred to in Article 1 of European Parliament and Council Directive
2004/10/EC [10] on the application of the principles of good laboratory
practice and the verification of their applications for tests on chemical
substances and shall take particular account of the following -
(a) the
general toxicological profile of each ingredient used;
(b) the
chemical structure of each ingredient;
(c) the
level of exposure of each ingredient;
(d) the
specific exposure characteristics of the areas on which the cosmetic product
will be applied; and
(e) the
specific exposure characteristics of the class of individuals for whom the
cosmetic product is intended.
(3) Subject to paragraph (4) below
and without prejudice to the protection in particular of commercial secrecy and
of intellectual property rights where a cosmetic product is manufactured or
supplied in the United Kingdom a responsible person shall ensure that the
information specified in paragraphs (1)(a) and (1)(g)
above shall be made easily accessible to the public by any appropriate means.
(4) For the purposes of
paragraph (3) above, the quantitative information required under paragraph (1)(a) shall be limited to information relating to dangerous
substances covered by Directive 67/548/EEC as amended.
(5) The person referred to in
paragraph (1)(f) must be -
(a) subject to paragraph (6) below, the holder
of an appropriate European diploma within the meaning of section 4A of the
Pharmacy Act 1954[11] or any other person who has the right, granted by a
competent authority in a Member State, to take up and pursue the activities of
a pharmaceutical chemist;
(b) subject to paragraph (6)
below, a person who is entitled to be registered under section 3(1) of the
Medical Act 1983[12] as a fully registered medical practitioner and who has the
right, granted by a competent authority in a Member State, to take up and
pursue the activities of a doctor; or
(c) the holder of a diploma
within the meaning of regulation 2(1) of the European Communities (Recognition
of Professional Qualifications) Regulations 1991[13] showing that the holder
has the qualifications required to practise as a
chartered biologist or that he has the qualifications required to practise as a chartered chemist or that he has the
qualifications required to practise a profession
equivalent to the profession of chartered biologist or chartered chemist in a Member State other than the United Kingdom.
In plain English - this is a list of the
information that makes up a PIP.
·
Product
description and codes or formulation code
·
Product formula
including percentages, INCI names, trade names and suppliers.
·
Raw material
ingredient specifications and technical data sheets (Dweck Data only ask for
this when they do not have any information on their own extensive data base
files)
·
Manufacturing
procedure summary or single page flow chart
·
Summary GMP
statement (a statement on company headed paper declaring ISO standards and/or
GMP compliance)
·
Product safety
assessment statement (signed by Dweck Data if required)
·
Undesirable health
effects summary – these are done by Dweck Data where appropriate
·
Claim
substantiation summary with references – this is proof that pack claims are
able to be substantiated.
·
Stability summary,
with reference to methods – this is usually a spreadsheet showing the stability
at ambient, 30ºC, 40ºC, freeze-thaw etc.
·
Specification –
viscosity, pH and other test data listed.
·
Microbiological
challenge test records for products that contain water.
·
Proposed pack copy
or artwork for each carton and label
·
Dweck Data also
like to include a picture of the final product in the PIP.
·
Perfumes and
flavours should have IFRA and/or RIFM compliance statements from the perfume
house.
·
Perfumes should
have the 26 potential allergens content list from the perfume house.
If your supplier or manufacturer is unwilling
to supply this information, then you cannot legally sell in