The key legislative market obligations you need to meet are:

Market access and customs status

• Determine whether the product is allowed in the target market and whether any quotas, embargoes, or import licences apply (e.g. automatic vs non‑automatic licensing under WTO rules).
• Identify the importer of record and confirm they hold any necessary registrations (e.g. EORI or equivalent, customs registration numbers, importer licences). An Importer of Record (IOR) is an agent who will handle all your customs and excise requirements for bringing the product into the market.

Tariffs, duties and taxes

• Classify the product using the Harmonized System / national tariff code to determine customs duties, trade defence measures and internal taxes (VAT, excise). For the EU market, a fiscal representative (particularly if you are selling business-to-consumer) is someone who can address your VAT requirements.
• Check whether a trade agreement or preference scheme applies, confirm rules of origin, and ensure you can evidence origin with appropriate certificates (e.g. EUR.1, Form A, REX statement, certificate of origin).
• You also have your Extended Producer Responsibilities (EPR), which are product and packaging waste registration requirements to meet Waste Packaging Directives. In the EU this normally requires an EU entity and as it is a fiscal related, it is best handled by your Importer (Importer of Record or Fiscal Representative).

Product safety, technical and SPS rules

• Identify all applicable horizontal and sector‑specific requirements (product safety, technical standards, conformity assessment, SPS/health controls for food, animals, plants, etc.)
• Confirm the product meets these requirements (testing, certification, inspections), including any mandatory conformity marks, notified body involvement, and approvals from competent authorities where relevant (e.g. market authorisation for medicines).

Labeling, packaging and documentation

• Map local labelling and packaging rules (language, mandatory particulars, safety warnings, recyclability and waste requirements, CE, weight markings, registration markings, other quality markings and relevant credentials)
• Prepare the full documentation set needed at the border and for regulatory files: commercial invoice, transport docs, import licence, product test reports, inspection certificates (health, veterinary, phytosanitary), declarations of conformity, and certificates of origin.

Post‑market obligations and oversight

• We are always happy to offer support with systems to address traceability, complaints handling, incident reporting or similar post‑market surveillance.
• Hopefully never an issue for you, but we do support procedures for recalls, cooperation with market surveillance or food/health authorities, and timely reporting of serious risks or adverse events in the destination country.

CERT aims for a clear simple approach to your regulatory requirements, allowing you to focus on your core business. A one price fits all would have been great, but not practical; as products vary in complexity and this would have penalised a lot of simple products having to subsidise more complex products.

So, the most cost-effective approach to it is a fixed one-off charge based on the complexity of the product.

This allows you to budget anf forecast your development costs and allows us to offer you an easy classification for the Regulatory Review Service, which matches the way we work.

The review charge is a fixed one-off charge defined by the complexity of your product and the number of markets for which a review is required:

Projects are normally costed upfront as a fixed cost to aid in budgeting and forecasting wherever possible. If your project is of an investigative nature, a fixed price is not always possible. In this scenario, we normally provide an estimate for the project on the proviso that if the project is looking to overrun, we will notify you at the earliest opportunity so that a commercial decision can be made. If a project does come in less than the estimate, the price is automatically adjusted accordingly.

For ad-hoc queries and short projects we actively encourage the use of the Bank of Time (BoT) as this cuts down on the administration, turnaround time and ultimately the cost of your project.
We like win-win scenarios!

Product Files exist to let a consultant review compliance and give advice , but the reviewer does not take on regulatory responsibilities. Regulatory review Product Files can be more flexible because it only needs to cover what is necessary for the agreed review.

The Product File is your dedicated space on CERTLabel’s system for uploading your files and information relating to a specific product for a regulatory review. The structure of the filing helps ensure nothing is missed during the regulatory review and reduces the risk of delays.​

You can upload as little or as much as you need: from a single label or artwork file for a quick compliance sense‑check, through to full technical documentation for a comprehensive product review. The scope of the review is entirely up to you and will follow the instructions you give when you submit the Product File.​

Using a dedicated Product File keeps each product’s paperwork separate and organised, which is especially important where you manage multiple SKUs or product variants.

For regulatory review, the Product File mainly supports evidence‑based advice and project traceability for the client. This can be used as evidence of a professional independent regulatory assessment and review if needed, but does not constiture product endorsement. If CERT are acting  as your market representative, you would be reading a different set of guidelines because in that scenario CERT would become the legal point of contact for authorities.

Do you need Market Representation support? (Authorised Representation/Food Business Operator/Responsible Person…)

All information you provide is held on a secure server (Office 365) using TLS1.2, encrypted data traffic using TLS and IPSec and multi-factor authentication.

You are provided with two-levels of access:

Read/write access – allowing you to upload and amend documentation on file and download any documentation you need. This does not allow bulk deletion or filing restructuring to help keep your documentation secure.

Administrator access – As this is your data and you own it, a nominated user(s) – the preference is to have a single administrator for simple clean point-to-point communication – who has a more secure access to the folder and is able to amend the details however they wish in the filing.

CERT take pride in providing clients with a quick turnaround on projects and officially aim to approve products within 5 working days. Realistically it often is sooner than that and depends on current work volumes. We appreciate your projects are important to your business and this requires good project management from us to avoid ‘bottlenecks’. You can help by submitting products as soon as possible for review, particularly for large volumes of product lines/SKUs. This helps to build in suitable time margins for us to ensure the products are correct and allow you time to deal with any gaps in information needed to complete the review.

The team cannot emphasise how important it is not to leave assessments to the ‘last-minute’, as projects under time pressure (i.e., needing less than a 24-hour turnaround) will incur a 25% surcharge on the assessment and does not leave any time margin to handle any missing information.

Once the terms of service has been approved, CERT will have your online secure filing up and running within 24 hours. This is to ensure we have a single point of communication and ensure details do not get lost in emails. You may be interacting with several members in the team depending on the technical expertise your project calls for and the filing also acts as a useful central reference point.

If you need to share data with a 3rd party e.g. shipping/customs/warehousing or client:

As already mentioned, your information is secure and is only accessed by yourselves and your CERT nominated regulatory professional. You may have instances where a 3rd party involved in your product distribution may ask for confirmation. DO NOT give them any secure links you have been provided with for your data, instead we recommend one of the following:

• • You can download and email a copy of the declaration provided by your Product Reviewer, confirming the product suitability which states the markets it has been confirmed for.

• • You could download the product folder and email it, but this may be bulky and puts your intellectual property at risk.

• •  For a small administration charge we can setup a temporary, read-only secure link, restricted to the person who requested it. Please note they can download information while it is available to them, but cannot alter or add any details to your product information.  This is the secure option for sharing a folder of information.

• • The most secure option – is access to a single document in your folder, that can be shared with a designated person, within a specific timeframe. The document is read-only and cannot be downloaded. This is the recommended route.

If you need  one of these service options, please contact your dedicated Product Reviewer for support.