TR CU 005/2011 is a technical regulation on packaging safety. Its application depends on what the packaging or closure is made of, what function it performs, what it may contact and how it is supplied. The first step is therefore to identify the packaging item itself, rather than treating the product inside it as evidence of packaging conformity.
A supplier should review the current regulation text before selecting evidence or a conformity route. The review should cover scope, exclusions, evidence, labelling and the applicable declaration route. Packaging conformity and contents conformity are separate questions.
What TR CU 005/2011 covers
TR CU 005/2011 concerns the safety of packaging. The relevant object may be packaging or a closure. The assessment starts with the physical item placed on the market, its materials, its intended use and the way it is supplied.
Material affects the assessment because packaging can contain one material or several material layers. A review should record the material or material layers shown in the technical information. A drawing can help identify the construction, interfaces and closure arrangement.
Function affects the assessment because a packaging item can serve a particular containment or closure purpose. The intended function should be stated in practical terms. A vague description such as “general packaging” may not be enough to determine which provisions of the current regulation text apply.
Intended contact affects the assessment because the same packaging format may be used for different contents. The review should identify whether contact with the contents is intended and what use the supplier has specified. Food contact requires particular care and should not be treated as automatically covered or excluded without checking the current text.
Which information determines the route
The applicable route depends on the identified packaging item and the provisions that apply to it. A supplier should not select a declaration route from the product name alone. The decision follows the product description, material information, intended contact, supply format, scope and exclusions.
- Identify the item. Record whether the subject is packaging, a closure or a component considered with the packaging.
- Describe the construction. Provide drawings and identify each material layer where the item has a layered structure.
- Define the use. State the function, intended contents and any intended contact.
- Record the supply format. Explain how the packaging is supplied, including whether it is supplied as a separate item or in connection with filling.
- Check the scope. Compare the identified item with the scope and exclusions in the current regulation text.
- Determine evidence and route. Use the applicable provisions to establish the required evidence, labelling and declaration route.
This sequence separates facts about the packaging from assumptions about its contents. It also prevents a supplier from applying one conclusion to every packaging format.
Packaging and its contents
Conformity of packaging is not the same as conformity of its contents. The packaging is the object assessed under the packaging safety requirements. The contents are a separate object with their own characteristics and possible requirements.
A declaration or other evidence relating to the contents does not, by itself, establish conformity of the packaging. Conversely, evidence concerning the packaging does not establish conformity of the contents. The supplier should keep these two assessment subjects distinct in the technical file and in any supporting records.
This distinction matters when a packaging item is supplied empty, when it is supplied with contents, or when the packaging is used during filling. The supply arrangement can affect how the item must be reviewed. It should be described before the route is chosen.
Food contact and filling operations
Food contact must be assessed from the intended use and the current regulation text. A packaging item should not be classified solely by its shape or trade description. The supplier should state whether contact with food is intended and provide the material and layer information needed for the review.
Packaging made during filling requires a separate check. The fact that an item is formed, closed or otherwise used during a filling operation does not support a blanket conclusion about its status under TR CU 005/2011. The supplier should describe the filling process, the item produced and the way the item is supplied.
These facts help distinguish the packaging from the contents and show whether the current regulation text includes the item or provides an exclusion. The result should be based on the identified object, not on a general assumption about food packaging.
Transport packaging
Transport packaging also requires a scope check. Its intended function and supply format should be recorded before applying TR CU 005/2011. Transport use alone does not justify either inclusion or exclusion.
The review should state whether the item is supplied as packaging for transport, whether it is also intended to contact the contents and whether it forms part of another packaging arrangement. These details may distinguish a transport packaging item from packaging intended for direct contact or another use.
Evidence and technical information
Evidence should relate to the packaging item identified in the review. The supplier should assemble information that describes the construction, materials, intended function, intended contact and supply format. Drawings are relevant where they show the form or layers of the item.
The current regulation text determines which evidence is applicable. It also determines the relevant labelling provisions and declaration route. This article does not replace that check because the route cannot be selected reliably without the product inputs.
A useful file should allow a reviewer to connect each conclusion with the packaging item. The material description should match the drawings. The stated use should match the intended contents and contact. The supply description should match the way the item is actually provided.
Labelling and the declaration route
Labelling is part of the conformity review. The current regulation text should be checked for the labelling provisions that apply to the identified packaging or closure. Labelling should not be copied from another packaging item merely because the format appears similar.
The declaration route is also determined by the applicable provisions of the current regulation text. A supplier should first confirm that TR CU 005/2011 applies, then identify the relevant requirements and only after that establish the route and supporting evidence.
Information to request from an overseas supplier
The following inputs support a focused review of TR CU 005/2011.
- A precise description of the packaging or closure.
- Drawings of the item and its construction.
- The material or material layers.
- The intended function.
- The intended contents and any intended contact.
- The way the item is supplied.
- An explanation of whether the item is made during filling.
- An explanation of whether the item is transport packaging.
These inputs do not replace the regulation text. They make it possible to compare the actual product with the scope, exclusions, evidence, labelling provisions and declaration route in that text.
Practical decision examples
If an overseas supplier presents a closure without drawings, the first action is to request the drawings and material information. The closure cannot be assessed accurately from its name alone.
If packaging has several layers, the review should identify the layers and their intended use. A general statement about the outer material may not describe the complete packaging item.
If packaging is supplied with contents, the reviewer should separate the packaging question from the contents question. The supply arrangement should then be compared with the current scope and exclusions.
If a supplier describes an item as food packaging or transport packaging, that description should be treated as a use input. It should not be treated as an automatic answer on scope or conformity.
Frequently asked questions
What is TR CU 005/2011?
TR CU 005/2011 is a technical regulation on packaging safety. It is applied by reviewing the packaging or closure, its material, function, intended contact and supply format against the current regulation text.
Does conformity of the contents prove conformity of the packaging?
No. Packaging conformity and contents conformity concern separate objects. Evidence for the contents does not, by itself, establish conformity of the packaging.
Is food contact automatically included in the same assessment?
No blanket conclusion should be made. The supplier must identify the intended food contact, materials and layers, then check the scope, exclusions, evidence, labelling and declaration route in the current regulation text.
What should be requested before reviewing an overseas packaging item?
Request drawings, material layers, intended use, function, contents, contact information and the way the item is supplied. Also ask whether the item is made during filling or is intended as transport packaging.
Check who makes the packaging
Article 1 of TR CU 005/2011 gives a narrower set of requirements for packaging or closures made by the manufacturer of the packaged product during production of that product. If that describes your supply, record who manufactures the packaging and at what point it is made. Check that case separately from empty packaging sold as a finished item.
For food-contact packaging, compare the materials and intended contact conditions with Annex 1. Annex 2 gives the model media used to evaluate migration. For a multilayer pack, identify the layer in contact with the food, along with the fill temperature, intended storage time and contact surface.
Compare the certificate and declaration routes and check what evidence applies to your product.