What does RecyFert do?
RecyFert builds and finalises EU FPR dossiers (Module A, Module B followed by C and Module D.1) in the Gilbert FPR software and keeps them ready for notified body and government surveillance audits. The economic operator stays responsible for the product, its technical documentation and its EU declaration of conformity.
Read more: What does RecyFert do?Which conformity assessment module do I need?
It depends on the component material categories (CMCs) in your product and its product function category (PFC), as set out in Annex IV, Part I of Regulation (EU) 2019/1009. Module A is for simple materials, Module B followed by C widens that to inhibitors, plants, micro-organisms, polymers and derived products, and Module D.1 can be used for any product except high-nitrogen ammonium nitrate fertilisers.
Read more: Which conformity assessment module do I need?What is the difference between Category 2 and Category 3 animal by-products?
Regulation (EC) No 1069/2009 sorts animal by-products by risk. Category 2 (Article 9) is medium risk, for example manure and animals that died other than by slaughter. Category 3 (Article 10) is the lowest risk and comes from healthy animals, for example slaughterhouse by-products, blood, feathers and fish. Only Category 2 and Category 3 material can be used in EU fertilising products.
Read more: What is the difference between Category 2 and Category 3 animal by-products?How much does an FPR dossier cost?
On the RecyFert licence: Module A € 600, Module B followed by C € 1,000 and Module D.1 € 1,800 per dossier. With your own Gilbert licence: Module A € 300, Module B followed by C € 700 and Module D.1 € 1,500 per dossier, plus the Gilbert licence of € 50 per month per dossier. Prices are in euro, exclude VAT and exclude notified body fees. Each price includes 2 revisions.
Read more: How much does an FPR dossier cost?Who is responsible for the dossier?
The manufacturer or other economic operator. By drawing up the EU declaration of conformity, the manufacturer assumes responsibility for compliance (Article 16(4)). RecyFert prepares and archives. Conformity decisions rest with the notified body or the competent authority.
Read more: Who is responsible for the dossier?How long must the dossier be kept?
The regulation requires the technical documentation and the EU declaration of conformity to be kept for 5 years after the product is placed on the market (Article 6(3)). RecyFert's archiving option costs € 100 per dossier per year and includes delivery to an auditor or authority within 24 hours.
Read more: How long must the dossier be kept?What happens to my dossier after 6 months?
On the RecyFert licence you have full access for 6 months and can generate the EU declaration of conformity and the technical documentation in different languages. After that you choose archiving, or access closes. If you need access later, it is treated as a new dossier.
Read more: What happens to my dossier after 6 months?Are notified body fees included?
No. Prices for Module B and Module D.1 exclude the fees of the notified body, which you pay to the notified body directly. RecyFert's on-premises audit preparation helps you get ready for the audit, attends it with you and handles the initial correspondence.
Read more: Are notified body fees included?Can I edit the dossier myself?
Yes, on the second route. You buy your own access to the Gilbert FPR software and give RecyFert edit rights. You can take over editing whenever you want, and archiving is included in your Gilbert licence.
Read more: Can I edit the dossier myself?In which languages can you deliver documents?
The EU declaration of conformity must be translated into the language or languages required by each Member State where the product is placed on the market. RecyFert can deliver documents for all 27 EU Member States.
Read more: In which languages can you deliver documents?Do you cover Module A1?
No. Module A1 is used for high-nitrogen ammonium nitrate fertilisers and certain blends containing them. RecyFert covers Module A, Module B followed by C and Module D.1.
Read more: Do you cover Module A1?