Global Standard for Packaging and Packaging Materials Issue 3 January 2008 Packaging Category Decision Tree Determination

Discussion and examples The outline is provided as a guide to help companies in the use and interpretation of the product category groupings. The company seeking certification must conduct a hazard and risk analysis which will establish a full description of the packaging product and the intended use by the customer. Identifying potential hazards and establishing control points will help to verify the packaging category that shall be established through application of the Packaging Category Determination Decision Tree. Once the company has determined the packaging category, it is recommended that this is verified with their customers as appropriate. The packaging category shall also be verified by the Certification Body. The purpose of the decision tree is to enable the user to determine the packaging category for the packaging products which they produce and ensure that the audit is conducted at an appropriate level suitable for the nature of the material being produced. The Global Standard identified 3 categories of packaging with regard to the standards of hygiene under which packaging is produced. For each packaging product manufactured, each of the questions is answered sequentially from the first question until a category is arrived at. Guidance is given to the interpretation of the questions however, the ultimate decision for the packaging category shall be agreed by the manufacturer and the customer and verified by the certification body. Generally the following packaging categories apply: Category 1 shall be packaging for high risk products e.g. packaging that comes into direct contact with products for human consumption, and direct contact with products for application to skin. Category 2 shall be packaging does not come into direct contact with high risk products. Category 3 shall be packaging for products with low risk with regard to standards of hygiene such as DIY, clothing and household products, but which clearly must meet defined functional requirements.

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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.

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Is the packaging intended for direct contact with a high risk product? It must then be determined whether the packaging will come into direct contact with the high risk product.

Does the high risk product have an adequate natural barrier? A natural barrier here would apply to foods such eggs, avocado, nuts or banana where the shell or peel is not traditionally eaten. For foods such as oranges, it must be agreed whether this constitutes a natural barrier as in some instances the peel itself would be eaten. Examples of other food stuffs such as sacks for potatoes could be included here. Is it intended that the packaging will enter an environment where there are unprotected or open high risk products? This examines the need for higher hygiene practices to be applied if the packaging is likely to enter the high risk production environment, even though it may not in itself come into contact with the high risk product, for example labels which would be applied to outer packaging of food. Is the product already in impermeable packaging? Impermeable (a material through which substances, such as liquids or gases, cannot pass) would be defined as a can, bottle or the like where the food product is packed and sealed and cannot be contaminated during labelling or further packed in an outer container. Does the packaging have the potential to contaminate the product? It should be considered what the contamination potential of the packaging to the high risk product is. This poses the question of whether the packaging or its constituent parts could contaminate the product or impart any flavours, colorants, loose fibres, clips, adhesive or any other item onto the food or skin contact packaging. For example it must be ensured that the packaging itself would not allow migration of chemicals for example that could contaminate food or leach into cream that would be subsequently applied to skin for example. This may not be an issue for products within category 3 for example. However, it should be noted that all products should conform to legislation and therefore this hazard should have been considered within the hazard and risk analysis.

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Worked Examples

1. Plastic laminate for toothpaste tube Is the packaging intended for a high risk product For example food or cosmetics products? Yes as this product is ingested Is the packaging intended for direct contact with a high risk product? Yes comes into direct contact with toothpaste

Does the high risk product have an adequate natural barrier? No CATEGORY 1

2. Cardboard outer box for cornflakes Is the packaging intended for a high risk product For example food or cosmetics products? Yes food product Is the packaging intended for direct contact with a high risk product? No outer packaging only, as cornflakes are in inner bag Is it intended that the packaging will enter an environment where there are unprotected or open high risk products? Yes may enter production environment whether cornflakes are packed Does the packaging have the potential to contaminate the product? Production environment and procedures designed so that packing is remote from open product and little potential for contamination CATEGORY 2

3. Plastic bag for nails Is the packaging intended for a high risk product For example food or cosmetics products? No low risk nails CATEGORY 3

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