PPWR
Technical documentation for packaging under PPWR Annex VII
Signing a declaration of conformity takes a minute. The documentation it rests on takes weeks. Here is what it has to contain, what it looks like for an ordinary supplement bottle, and when you need to update it.
Who prepares it
The manufacturer prepares the technical documentation, usually the brand the product is sold under (Article 15(2)). It does this itself, without a certification body, and declares on its own responsibility that the packaging meets the requirements.
This obligation cannot be passed to an authorised representative (Article 17(2)). You can outsource the preparation of the documents to an external company, but the signature and the responsibility stay with the manufacturer.
What it has to contain
Annex VII, point 2, lists six elements. On top of that comes a risk analysis and assessment.
- A general description of the packaging and its intended purpose.
- Design, technical drawings and the materials each component is made from.
- Descriptions needed to understand the drawings and how the packaging works.
- A list of the standards applied, or a description of the solutions adopted where none were used.
- An account of the assessments under Articles 6, 10 and 11, covering recyclability, minimisation and reuse.
- Test results.
A worked example: a supplement bottle
A typical package is a PET bottle, a closure with a liner, a label and a carton. Each part usually has a different supplier.
In the description you give the type of packaging, its purpose and the products that use it. For materials you collect a technical data sheet for each part, with the material and weight.
For tests you need results on heavy metals and PFAS for each component. A supplement's packaging touches food, so documents required for food-contact materials come on top (Article 16(2)).
Recyclability and minimisation criteria start applying from 2030 at the earliest, so for now you describe the current state. The reuse assessment applies only to packaging meant to be reused.
Risk analysis
This is the element most often missing, because no supplier will send it to you. The Regulation does not say how it should look. The point is to know what could go wrong and how you are preventing it.
For each component you check whether you have evidence and whether it is reliable. A risk might be a PFAS test done on a different colour, a declaration expiring in six months, or a supplier that could change a raw material without warning.
For each risk, note what you are doing about it. That might be a request for testing, a renewal deadline, or a clause in the contract.
The EU declaration of conformity
Once the documentation confirms conformity, the manufacturer signs the EU declaration of conformity (Article 39), one for each type of packaging, using the template in Annex VIII.
- A declaration number and a precise identification of the packaging.
- The manufacturer's name and address.
- A statement that the declaration is issued under the manufacturer's sole responsibility.
- A description of the packaging that allows it to be identified.
- The requirements the packaging complies with.
- The standards applied.
- Place, date, name, position and signature of the person issuing it.
How long to keep it
Keep the documentation and the declaration for 5 years from the packaging being placed on the market, or 10 years for reusable packaging (Article 15(3)).
On an authority's request you send the documents electronically within 10 days (Article 15(10)). The declaration has to be in the language of the country where you sell (Article 39(2)), so selling abroad means you need translations.
When to update it
The declaration has to be kept up to date at all times (Article 39(2)). When the packaging changes, you need to check it again (Article 15(4)).
A new supplier, a different material, colour, weight or shape all call for a fresh check. So does a new label or an expired supplier declaration. Without a component list it is easy to miss such a change.
The most common gaps
These are the gaps that turn up most often in documentation companies put together themselves.
- No risk analysis.
- Documents cover only the bottle, not every component.
- It is not clear which products the declaration covers.
- Documentation and declaration are merged into one document, instead of being kept separate.
- Nobody tracks changes at suppliers.
Sources
This article is for information only and describes the legal status as of the date shown. For your specific situation, write to us and we will look at it.