☰
Workshop Training › Live Webinars › Download Factsheets › PPWR Assessment

How to Achieve EU Conformity: Requirements, Documentation & Declaration Process

Discover how to achieve EU conformity under PPWR, from meeting requirements to preparing your EU conformity declaration with the right documentation and compliance services.

To sell goods or packaging in Europe, you must follow tight rules. It is against the law not to meet EU conformity. Companies must fill out an EU conformity declaration, keep good records, and follow a set method for compliance.

This guide clearly and practically explains the requirements, how to format your documentation, and how to make a declaration.

Key Takeaways

  • EU conformity is obligatory for the sale of products or packaging in the European market, and companies have to comply with formal procedures.
  • A well-organized EU conformity declaration is a formal document that states the product complies with all EU laws and regulations.
  • It is important to have all technical information accurate to support your EU declaration of conformity.
  • Compliance services can help companies avoid risks and ensure a smooth entry into the EU market.

EU Conformity Process & Steps at a Glance

Below is a step-by-step overview of the EU conformity process under PPWR, from identifying applicable laws to maintaining compliance documentation.

StepWhat You Must DoKey Output
1. Identify Applicable EU LawsDetermine which EU regulations and harmonised standards apply to your product or packaging (including PPWR for packaging)Compliance roadmap
2. Conduct Conformity AssessmentPerform required testing and verification (self-assessment or via Notified Body if required)Verified compliance
3. Prepare Technical DocumentationCompile product details, risk assessments, test reports, standards used, and conformity procedureTechnical file
4. Draft EU Declaration of ConformityInclude manufacturer details, product ID, applicable laws, standards, compliance statement, signatureSigned EU DoC
5. Maintain Ongoing ComplianceKeep records (up to 10 years), update documents if regulations change, provide to authorities upon requestAudit readiness

What does it mean to be EU compliant?

For a product or package to be EU-compliant, it must meet all of the EU’s rules and criteria. Before an item may be sold in the EU, it must meet safety, environmental, and performance regulations.

The manufacturer or authorised representative gives you a EU conformity declaration (sometimes called an EU Declaration of Conformity or EU DoC). The company agrees to take full responsibility for compliance by signing this form.

The EU Packaging and Packaging Waste Regulation (PPWR) says that packaging must have a valid EU declaration stating it meets requirements for recyclability, materials, and sustainability.

Step 1: Find the EU laws that apply

Finding out which EU rules apply to your product or packaging is the first step toward making sure it meets EU standards.

Different rules apply to different types of products, like electronics, machinery, medical devices, and packaging. The PPWR sets rules for packaging that include requirements for recyclability, material composition, labelling, and cutting down on waste.

At this point, businesses need to:

  • Find EU rules or directives that apply
  • Look over the relevant harmonised standards
  • Know what they need to do to follow the rules for their product

This stage lays out the whole plan for compliance.

Step 2: Do a conformity assessment

Once the laws are identified, a conformity assessment has to be carried out. This procedure ensures that the product meets the EU requirements.

Depending on the type of product:

  • Some products allow the manufacturer to carry out the assessment themselves
  • Some require a Notified Body to be involved

In the case of PPWR, this may include examining the material information, testing to ensure it complies with sustainability requirements, and assessing whether the packaging is recyclable.

At this stage, good judgment reduces the risk of surpassing the law at a later stage.

Step 3: Get the technical documents ready

In order to follow EU regulations, you will need technical documentation. This will prove that your product complies with all regulations.

When audited or inspected, you may be asked for this documentation.

Most of the time, technical documentation has:

  • Description of the product or package
  • Information on design and production
  • Assessments of risk
  • Reports and results from tests and analyses
  • List of standards that were used
  • The procedure for checking conformity was followed
  • A copy of the EU compliance declaration

For packaging, the paperwork must clearly show that it meets the requirements of the PPWR Articles and can be recycled.

Depending on the rule, records must be kept for several years. The official statement that confirms compliance is the EU conformity declaration. It needs to be in a certain format and have certain information.

An EU declaration should have:

  • Name and address of the manufacturer
  • Information about the product’s ID
  • References to EU laws that apply
  • Used standards that were the same
  • Statement of responsibility for compliance
  • Information about the notified body (if appropriate)
  • Name, place, date, and signature of the person who is allowed to sign

The declaration needs to be correct, easy to find, and available to the authorities when they ask for it.

What Compliance Services Do?

It might be hard to figure out how to meet EU compliance standards, especially for businesses that work outside the EU or sell a lot of different products.

Professional compliance services help businesses by:

  • Finding rules that apply
  • Research and check thoroughly to make sure things are in line
  • Writing technical documents
  • Writing declarations of compliance for the EU
  • Taking care of PPWR compliance duties
  • Making sure that paperwork is always ready for an audit

These services help lower risk, stop delays, and make it easier to enter the EU market. After making the EU statement, businesses must:

  • Keep records for the required amount of time (usually up to 10 years)
  • If the rules or standards for the product change, update the EU conformity statement
  • Give EU authorities documents when they ask for them

For continued compliance, it is important to keep records that are up to date and correct.

To Sum Up

It’s not only a rule that you have to follow to be EU-compliant. It’s a big step toward getting into and doing business in Europe. Each step, from finding the right laws to writing technical documents and producing a legal EU conformity certificate, must be done carefully and correctly. Businesses that have to deal with PPWR and other EU declaration obligations can make things easier and less risky by hiring skilled compliance services. 

PackIntelX helps you every step of the way to make sure your EU compliance paperwork is full, well-organised, and ready for an audit. Contact PackIntelX today to make sure your EU compliance procedure goes smoothly and is always reliable.

Share:

More Posts