Global Standard for Packaging and Packaging Materials Issue 3 ...

It is recognised that many manufacturers or suppliers fall into more than one Category. In
these circumstances they may either choose to use one category for the entire factory or
separate them by areas. It is not envisaged that more than one category would apply within
the same area.
Is the packaging intended for a high risk product – For example food or cosmetics
products?
A high risk product has been defined in the glossary as:
‘those products intended for human consumption or which will come into close contact
with the body such as application to the skin or are intended for infants.’
Infants are defined as children under the age of 36 months.
This question is intended to identify the initial hygiene requirement for the packaging.
Although it can be said that clothing such as hosiery, lingerie, shirts and
blouses are designed to come into close contact with the skin, these would not be
considered ‘high risk’ products and so the answer here would be ‘no’ and packaging for
such clothing would be category 3.
Jewellery is also an example of a product that technically could be in contact with the
skin, but in most cases would be identified as category 3.
Products which would be considered as high risk are:
Those for human consumption would include foods and medicines. Medicines would be
include any product that is controlled under the medicines directives (legislation) where
the product is sold. Products that are defined as medicines in the EU many not be defined
as such in other countries such as the USA.
It may be agreed by the manufacturer and customer that consumed products other than
those for humans e.g. pet foods may fall into a high risk product group and therefore
category 1.
Products that would come into close contact with the skin may include:
Cosmetics – Any product that is controlled under the Cosmetic directives (legislation)
where the product is sold. In the UK a non woven product such as a cosmetic wipe would
be sold as a cosmetic and would be defined under the legislation as such. Examples of
other typical products that would be sold as cosmetics include cosmetic wipes such as
make up remover wipes, baby wipes, medicated shampoo, perfumes, anti wrinkle creams,
lipsticks and moisturisers.
Medical Device- Any product that is controlled under the legislation as a medical device
in the country where the product is sold. In the UK plasters that are designed to put over
wounds and incontinence pants are both defined under the legislation as medical devices.
Other examples of typical medical devices would include wound plasters, incontinence
pads, condoms, contact lenses, and supportive bandages.
KLH Page 2 of 4 Updated on website 7.1.08