Organic · Regulation (EU) 2018/848 and USDA NOP, 7 CFR Part 205
EU and USDA organic certification: the legal right to sell your product as organic.
In the European Union and the United States, the word organic on a label, invoice or website is reserved by law for certified operations. Sterling's expert and experienced consultants translate both rule sets into field, factory and warehouse routines, build the records an inspector follows from input to sale and prepare you for the inspection, in 60+ countries. We ensure successful certification for our clients.
- Fixed scope, one proposal: consulting, Effivity software, Sterling Academy access and internal auditor training, as applicable to your standard, in one proposal
- A team of expert and experienced food-chain consultants, advising on management systems across sectors and countries since 2003
- The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements. Sterling does not certify; your control body or certifying agent inspects and decides
8,100+ client engagements in 60+ countries.
Organic client experience
What it is
What is EU and USDA organic certification?
Organic is not a voluntary badge in these two markets; it is a regulated claim. In the EU, Regulation (EU) 2018/848 sets the rules for organic production and for labelling organic products, and every operator in the chain notifies its activity and is certified by a control authority or control body before it may sell as organic. In the US, the National Organic Program regulations in 7 CFR Part 205 require every operation, or portion of one, that produces or handles products sold, labelled or represented as organic to be certified, unless an exemption in the rules applies.
Both regimes ask how the product is produced, how organic product is kept apart from conventional, what the label may say and whether the records prove it. A certificate from one market does not by itself open the other, which is why exporters often need both.
Current rules. Regulation (EU) 2018/848 of 30 May 2018 repealed Council Regulation (EC) No 834/2007 and has applied since 1 January 2022, supported by Commission delegated and implementing acts, with transitional periods for some provisions, in particular on trade. In the US, the Strengthening Organic Enforcement rule, published on 19 January 2023, amended 7 CFR Part 205 with an implementation date of 19 March 2024.
Who it is for
Who needs organic certification?
Growers are only the start of it. Anyone who produces, prepares, stores, imports, exports or trades products sold as organic may fall within scope, and the Strengthening Organic Enforcement rule widened the circle of US operations that must be certified. Organisations come to Sterling for organic certification from four starting points:
- A retailer or importer asks for your certificate. Buyers check certificate status before they order, and the organic premium goes the day your status is in doubt.
- A tender or distribution contract names organic product. Confirm which market's rules the contract means before you start.
- You export into a regulated market. Consignments entering the EU need an electronic certificate of inspection in TRACES, and the SOE rule introduced NOP Import Certificates for the US; both depend on a certified supply chain behind them.
- A group company, parent brand or co-packer needs you in its chain. An ingredient supplier, contract manufacturer or warehouse handling organic stock can break the chain for the brand if it is not certified.
Requirements
What are the main organic certification requirements?
The EU regulation is organised in nine chapters and the US rules in seven subparts. The list below shows the parts an operator works with day to day, in plain language; your gap analysis checks your operation against the full text that applies to your products and activities.
- EU Chapter II, Objectives and principles of organic production: the aims and principles that every production rule serves.
- EU Chapter III, Production rules: the rules for producing organic and in-conversion products, by type of production.
- EU Chapter IV, Labelling: when and how products may be labelled and presented as organic.
- EU Chapter V, Certification: notification of your activity, the certificate, and certification of a group of operators as one unit.
- EU Chapter VI, Official controls and other official activities: the official controls operators are subject to, and the action operators and authorities take when compliance is in question.
- EU Chapter VII, Trade with third countries: import through recognised control bodies or authorities, equivalence and trade agreements.
- US Subpart C, Organic Production and Handling Requirements: the organic production or handling system plan and the practices that keep organic product organic.
- US Subpart D, Labels, Labeling, and Market Information: what labels and market information may say, including the SOE rules for nonretail containers.
- US Subpart E, Certification: application, initial and annual on-site inspections, annual updates and the certificate of organic operation.
- US Strengthening Organic Enforcement: fraud prevention, recordkeeping and traceability, NOP Import Certificates, unannounced inspections and producer group rules.
What does useful organic evidence look like?
Purchase records for every input, checked against what the rules permit; supplier certificates confirmed as valid on the day of purchase; a mass balance that reconciles organic product in and out; cleaning and segregation records wherever organic and conventional share a line or a store; label approvals; a fraud prevention assessment; and import or export certificates filed against each consignment. In Effivity each is a register kept as the work happens.
Certification process
How do you get organic certified in the EU and the US?
You build a control system first; a certifier then inspects it and decides. Sterling prepares your operation and stays with you through the inspection. The certificate is issued by the control body, control authority or certifying agent, and that independence is what buyers rely on.
- 01Decide markets, products and activities.EU, US or both; growing, processing, storage, import, export or trading; one operation or a group; the sites and products the certificate must name.
- 02Gap analysis: compare current practice with the rules.Inputs, segregation, labels, suppliers and records checked on site against each applicable rule set, with actions, owners and dates agreed.
- 03Choose the certifier and apply.An EU operator notifies its activity and is controlled by a control authority or control body; outside the EU, a body recognised by the Commission or the equivalence route; in the US, an accredited certifying agent and an organic system plan.
- 04Pass the inspection and the certification decision.On-site inspection of each unit, facility and site in scope, a trace from input to sale, findings answered with evidence, then the certifier's decision.
- 05Stay certified every year.Annual updates and on-site inspections, possible unannounced visits, supplier certificates rechecked, and import or export certificates for each consignment.
Check the certifier before you sign. For the US, find the agent in the USDA Organic INTEGRITY Database and confirm its scope covers your products and country. For EU imports, confirm the body appears on the Commission's lists of recognised control bodies and authorities for your country and product category. Inside the EU, the competent authority in your member state names the bodies it has delegated. How to choose a credible organic certifier · The certification buyer's checklist
Cost
How much does organic certification cost?
A single farm selling into one market and an importer consolidating hundreds of consignments for two markets are different projects. The components are the same, and a Sterling proposal shows each of them, with the fee fixed.
| Cost component | What affects it |
|---|---|
| Consulting and implementation | One market or two, the activities and products in scope, whether a group internal control system is needed, and how much of the work your team carries (Design™ or Drive™) |
| Certification and inspection | The certifier's fees, inspection time, travel and sites, the annual inspection, and any sampling or residue analysis it requires |
| Internal resources | Time from operations, purchasing and quality staff; changes to storage, cleaning or line scheduling; relabelling |
| Software and learning | Included in a Sterling engagement: Effivity for records and Sterling Academy access for your people, with users, courses and the access period set out in the proposal |
| Continued support | Annual updates, pre-inspection reviews, supplier monitoring and rule changes under Sustain™ |
What moves the price
- The number of sites, products and ingredients in scope
- Whether organic and conventional product share lines or stores
- The length and spread of your supply chain, and how many suppliers need checking
- Import and export volumes, and the certificates each consignment needs
- Whether one rule set applies, or both
What a Sterling proposal always shows
- Deliverables, responsibilities, assumptions and exclusions, written down
- Certifier fees shown separately, so the whole programme can be compared
- Effivity, training and Academy access itemised at no additional cost
- Payments linked to deliverables
- One all-inclusive proposal. No surprises, ever
Timeline
How long does organic certification take?
For a processor, trader or importer, or a farm whose land already qualifies, our estimate is four to nine months. Land still in conversion follows the time the rules set, and no project plan shortens it. Within that, pace is set by how quickly suppliers produce valid certificates, how much segregation work is needed and when the certifier can inspect.
| Phase | What determines the pace |
|---|---|
| Scope and gap analysis | Decisions on markets and activities, and access to sites, suppliers and records |
| Controls and records | Changes to sourcing, storage, cleaning and labels, and supplier responses |
| Application and plan | The certifier's review of the application and the organic system plan |
| Inspection and decision | The inspection date, harvest or production timing, and closing any findings |
Share your first shipment or contract date at the outset. We will tell you plainly what can be achieved by then and which decisions must be taken early.
Your engagement
What your organic certification engagement includes
Sterling does not certify; the control body, control authority or certifying agent inspects and decides. Our work runs on Sterling OS™: you choose Design™, where we guide and your team builds, or Drive™, where we manage the work with you; Automate™ is Effivity carrying the records; and Sustain™ keeps you ready for every annual inspection after certification.
Scope, gap analysis and plan
Markets, activities, owners and dates agreed before any work begins.
Organic system plan and procedures
Sourcing, segregation, cleaning, labelling and traceability written around how your site really runs.
Effivity ISO & GRC software
Records and registers in Effivity from the first week, included with the engagement at no additional cost.
Training for everyone
Internal auditor training for your audit team, as applicable to your standard, and preferential Sterling Academy access, including complimentary awareness training for your people as part of the engagement.
Internal audit and trace tests
Mass balance and trace-back exercises run before the inspector arrives, with gaps closed.
Inspection readiness and support
Preparation for the inspection and support until the certificate is issued.
Certification decisions remain with the control body, control authority or certifying agent.
Often combined with
Standards organisations pair with Organic (EU / USDA NOP)
- BRCGS Food SafetyBRCGS Food Safety certification consulting for food manufacturers: HACCP plan, site standards and controls ready for a graded audit, announced or unannounced.
- BRCGS Storage and Distribution · Agents and BrokersBRCGS Storage and Distribution certification and Agents and Brokers: Issue 4 and Issue 3 requirements, scopes, audits and cost factors, with Sterling's support.
- FairtradeFairtrade certification and requirements: which Fairtrade International standards apply, FLOCERT's audit, cost and timing, and how Sterling prepares you.
- FAMI-QS / GMP+FAMI-QS and GMP+ certification for feed businesses: how the two schemes differ, their requirement documents, the audit route and how Sterling prepares you.
- FDA FSMA (US)FDA FSMA compliance for food facilities, importers, farms and carriers: preventive controls, FSVP, food traceability and records ready for FDA inspection.
- FSSC 22000FSSC 22000 certification consulting for GFSI-recognised food safety: ISO 22000, sector PRPs and FSSC requirements, ready for a licensed body's audit.
Effivity · ISO and GRC software, included in every engagement
How Effivity helps you fulfil, automate and simplify the requirements of EU and USDA organic rules.
Each Sterling organic engagement includes Effivity, the ISO and GRC automation platform built by the Sterling group and used in 50+ countries. Your consultant sets up the workspace within the agreed scope, so input approvals, supplier certificates, mass balances, cleaning and segregation records, label approvals, complaints, audits and corrective actions sit in one place and the inspector follows a live trail rather than a stack of files. Sterling consulting clients get their Effivity subscription included with the engagement, at no additional cost.
Scope, sites and certificate status
Sites, products, activities and the certificate's expiry held in one record, with reminders ahead of the annual update.
Input approval and use
Seeds, feed, fertilisers, cleaning agents and ingredients approved before purchase and logged when used.
Organic system plan
The plan kept current, with changes recorded and ready to send to the certifier.
Suppliers and consignments
Supplier certificates checked for validity, and import or export certificates filed against each shipment.
Label and claim approval
Every label, pack and product claim approved against the rules for its market before it is printed.
Inspections, findings and corrective action
Certifier findings and internal findings tracked to closure, with evidence attached.
Traceability and fraud prevention
Mass balances, trace tests and the fraud prevention assessment kept as live records.
Your own processes, forms and reports
Forms, fields, workflows and reports shaped to your operation without code.
What this means at the inspection
An inspector picks a finished lot and asks you to trace it back to its inputs and suppliers, then checks the quantities balance. In Effivity that trail is already assembled, with dates and certificates attached. After certification, Sustain™ uses the same workspace, so each annual inspection finds records that kept running.
In your engagement
- Subscription included with the engagement, at no additional cost
- Configured by your Sterling consultant within the agreed scope
- Your documents, records and registers migrated, not retyped
- Admin and user training for your team
- Modules for EMS, OHSMS, ISMS, FSMS and more when you integrate other standards
Sterling Academy · organic e-learning
Train the people who keep organic product organic.
Sterling Academy runs e-learning for the whole workforce and for those who manage the system, with video lessons, practice checkpoints, a final exam and a numbered Certificate of Completion each learner can verify online. Sterling consulting clients receive preferential Sterling Academy course access and special pricing through their Sterling consultant, including complimentary awareness training for their people as part of the engagement.
- Awareness for warehouse, production and purchasing staff who handle organic product
- Internal auditor training for your audit team, as applicable to your standard, as part of the engagement
- Learner progress by site and a training record ready for the inspector
- New starters trained on arrival, so records stay current between inspections
Keep exploring
Explore more about Organic (EU / USDA NOP)
Why Sterling
Want successful organic certification? Come to Sterling.
Organic supply chains cross borders: a grower in one country, a processor in another, a buyer in a third. Sterling works across that chain, so each link keeps records the next one, and the certifier, can rely on.
60+ countries, offices in 18, since 2003
One engagement team accountable wherever your farms, plants and warehouses sit.
All-inclusive proposal
Consulting, Effivity, training and Academy access in one proposal, with certifier fees shown separately. No surprises, ever.
Records that trace
Controls built into purchasing, receiving and dispatch, so the trail exists before anyone asks for it.
Expert and experienced consultants
Consultants who have advised on management systems across the food chain and who set up your organic controls properly the first time.
The Sterling Promise
What our organic certification success guarantee means
We stay with you until your agreed organic certification outcome is achieved, supporting implementation, preparation and the resolution of inspection findings. Clear explanations, practical delivery, included software and employee learning turn the investment into lasting capability rather than a certificate on a wall.
The engagement identifies the rules, scope, outcome and responsibilities. Your organisation supplies accurate information and puts the agreed controls into use. The control body, control authority or certifying agent assesses compliance and retains its certification decision. Our commitment concerns the agreed certification support, not a promise of every future contract award or error-free delivery.
FAQs
Frequently asked questions about EU and USDA organic certification
Does one organic certificate cover both the EU and the US?
Not automatically. They are separate legal regimes and each market decides which certificates it accepts. The Commission lists the USA among the countries recognised for equivalence, so confirm with your certifier how that applies to your products and route before relying on it.
Do traders and importers need organic certification if they never open the pack?
Often yes. EU rules require operators to notify their activity and be certified, and the US Strengthening Organic Enforcement rule expanded who the regulations apply to and changed the exemptions from certification. Whether your activity is exempt is a question to settle with your certifier at the start.
What changed under the Strengthening Organic Enforcement rule?
It tightened oversight of the US organic chain. Published on 19 January 2023 and implemented on 19 March 2024, it brought more operations into certification and introduced NOP Import Certificates, unannounced inspections, fraud prevention and stronger traceability and recordkeeping.
How do we export organic products to the EU from outside the EU?
Through a certifier the EU recognises for your country, and with an electronic certificate of inspection in TRACES for each consignment. Depending on the country, that is a control body or authority recognised by the Commission, or the system of a country recognised as equivalent. Without the e-COI, the goods are not released at the port of arrival.
Does Sterling issue organic certificates?
No. Sterling prepares your operation and supports you through inspection. Certificates are issued by control authorities or control bodies in the EU system and by USDA-accredited certifying agents in the US, and we work alongside your legal advisers where interpretation of the rules is needed.
Keep exploring
More on Organic (EU / USDA NOP) and related standards
More in Food safety & agriculture
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