- Certification in Europe: entering the European market
- Equipment certification
- Certification of medical products
- Specificities of obtaining CE marking for construction materials
- Food industry certification
What is needed for deliveries to Europe
Many companies are thinking about exporting their products. This is not without purpose, because export is:
- a way to expand the market;
- development of the company and a new approach to business;
- economic profitability based on an additional source of increased profits for the company.
Undoubtedly, companies that are interested in exporting their products and decide to enter foreign markets have a number of advantages and opportunities, but the key problem is that many of them are simply afraid to enter other markets without knowing their «rules of the game». There are a number of restrictions, barriers and mandatory documents in each country, which may be too complicated for the manufacturers. Particularly difficult and unclear is the legislation of the Union of certification procedures for the right to affix the CE mark.
In global consideration the procedure of certification can be divided into several directions:
- mandatory certification;
- certification of a product or company (its quality system).
Mandatory certification procedures for the European Union can be broken down into the following steps:
- Determine the directive(s) that apply to your product. European Union directives are a legislative instrument that sets mandatory requirements in the design, manufacturing, marketing and disposal process of production. In case if the product does not comply with the directives that require CE marking, this mark cannot be applied. Also, quite often the product may fall under several laws, and then all requirements must be taken into account.
- Conduct product testing in an accredited laboratory for compliance with international / European standards. If after testing it turned out that the product does not comply with all aspects of safety, carry out corrective actions.
- Also, the manufacturer is obliged to verify special requirements for national regulations, labeling, packaging and recycling in the country to which the products will be delivered.
- It is recommended to certify the quality system of the enterprise (but not necessarily). A quality system certification will increase the chance of obtaining CE mark. It is important to find a representative company in Europe. A representative in Europe is a legal entity located on the territory of the European Union that will represent your interests. Complaints and reclamations on your products will be addressed to this entity, so you must make sure that everything has been done correctly for certification. The representative may not be your dealer and not conduct economic and commercial activities, as it is simply the one who will be responsible for your products in the EU.
- Contact the Notification Body / NB for checking documents and issuing a certificate. All notified bodies in the EU are listed in a special open registry where you can see all the data on the body. This registry is called NANDO (New Approach Notified and Designated Organizations) Information System. Bodies that are officially registered and are functioning according to the necessary directives can be found by the following reference. If the forms and documents are filled out incorrectly, the NB will refuse to issue a certificate, but you can submit them again in 3 months only after you confirm the changes made. It is worth noting that Notification Body is reluctant to take on products that have been given critical quality marks or in case if a certificate has been previously withdrawn, since the validity of issuing the certificate will be checked in detail by the regulatory authorities with the accreditation of the Notification Body itself.
- Draw up a technical file and an EU Declaration. Technical file is a document containing requirements for the design, production, handling, operation and disposal of the product. Requirements for documentation vary depending on the Directive, so you need to know clearly what nuances your particular product will require. In the EU declaration you must specify all the Directives applied to the product, as well as unified standards, test reports and certificates.
- The final stage is marking the product, in respect that CE + CE ≠ CE. This formula means that the presence of the CE components does not give the right to affix the CE mark to the final product. It must undergo examination for compliance with the Directives and harmonized standards. The CE mark is the only mark of conformity in the European Union. By placing the CE on its products, the manufacturer makes it clear to the supervisory authorities that the products meet the agreed requirements and are safe; moreover, the manufacturer guarantees their safety.
Terms and conditions for applying CE-Mark:
- The CE mark is applied to the product or to the nameplate so that it is clearly visible, legible and indelible. If product characteristics do not allow this to be done or it is not justified, the mark should be seen on the package and in the accompanying documents, if the current legislation provides for these documents.
- CE mark is applied prior to export. An icon or any other sign indicating a hazard or a specific way of application may be placed next to it.
- The CE mark must be followed by the identification number of the notified body if the body participates in the production control phase and this is determined by one of the certification modules. The identification number of the notified body should be affixed by the body itself or, with its instructions, by the manufacturer or an authorized representative.
- The member states of the European Union ensure the proper application of the mechanism governing the CE marking and take the necessary measures in case of misuse of the marking.
- The harmonized specification contains detailed information on how the mark should be applied to a specific type of product. It is also important not to confuse this sign with a similar China Export sign.
The China Export mark is essentially not a fake, it is a misleading move to confuse European consumers. The China Export mark has no registration, confirmation of testing, and is arbitrarily placed by Chinese manufacturers of products.
In the European Union there is no unified list of products subject to mandatory certification. Some products, for example, are not subject to binding directives and regulations. Surprisingly, these are food products (fish and meat, bakery products, confectionery products, canned meat and vegetables, etc.). It should be noted that for the customer the main thing is that the goods meet the requirements of consumers, so he can set the requirements for the products himself.
Concerning food products, even various retail chains may have different requirements:
- some of them require the FSSC 22 000 Food Safety Systems Certification standard to be implemented at the manufacturer’s plant (usually, large hypermarket chains accept products only after the provision of this certificate);
- some of them are satisfied with the standards ISO 9001 «Quality Management System» or ISO 22 000 «Food Safety Management System».
In such cases, we advise you to clarify with a potential client what his requirements will be. Sometimes it happens that there are no specific requirements.
In addition to the mandatory certification, there is also a «voluntary-compulsory» certification. The manufacturer may pass such certification voluntarily, but during the tender a potential buyer has the right to set this condition as mandatory, and then there will be nothing left to do but comply with this requirement.
If your products are of good quality, you may not worry about compliance with the requirements of any country provided that you prepare all the necessary documents correctly.
Products falling under certification
Any products that enter the internal markets of the European Union must necessarily have permits confirming the compliance of this product with one or another standard. Depending on the type of product, there are different requirements for the issuance of permits and, accordingly, there are different documents that give the right to import products into the EU. But the universal core document of the European Union is the EU Declaration of Conformity.
There are two main types of product conformity assessment: declaration and certification in the EU. At the moment, measures have been taken to optimize this process in order to simplify the importation of products into the EU. For example, it is enough to transport a wide range of products followed by the EU Declaration of Conformity. There are also certain types of products that need to have a EC Certificate of Conformity. First of all, this concerns equipment that has electrical parts.
Although the EC Declaration of Conformity is required, sometimes it is not enough to have it. Electrical equipment is a hazardous product, and in this case, the manufacturer or exporter is obliged to carry out tests for obtaining not only the Declaration, but also the Certificate.
Also, this procedure is mandatory for equipment operating under pressure, explosive equipment, medical equipment and equipment associated with lifting mechanisms. Depending on the level of complexity of the equipment that falls under the mandatory certification, there are various conformity assessment modules, but the main document allowing entry into the EU markets remains the EU Certificate of Conformity. The scheme of conformity assessment modules is presented in the figure.
As we found out in the first article, certification can be mandatory or voluntary. It depends on the goals of the company. Mandatory «gives way» to the product on the selected market, and voluntary improves its position on the same market. Thus, the presence of a voluntary certificate is not only a good advertisement for a product, but is often a decisive factor in holding tenders.
The most important standard for voluntary certification is ISO 50001 and the corresponding ISO 50002, ISO 50003, etc. These standards provide a more efficient use of energy through the development of an energy management system (EnMS). Also, the standards ISO 9001, ISO 14001, ISO 45001 are necessary for the export of equipment.
In the EU countries there are several types of legislative regulatory documents, according to the requirements of which products must undergo a conformity assessment procedure:
- Certification according to EU Directives. As a result of the procedure, a recognizable CE mark is applied. Such mark means that the product has passed all the necessary procedures and is safe to use. There are about 30 European directives, and they regulate, for example, the certification of medical devices, machines, power equipment, etc.
- Certification under EU regulations is slightly different from CE certification. There are more regulations, and most often they set specific requirements for certain product categories. After passing this procedure, the CE mark is not applied, but a certificate is issued.
According to the new directive, equipment is a block of connected parts or components, of which at least one is set in motion. This includes interchangeable equipment that modifies the functioning of the equipment, as well as safety components. In order to enter the EU market, it is necessary to take into account one of the most important rules — your products must comply with safety requirements, which are indicated in European standards and directives. Exporting certain equipment, of course, implies some nuances and peculiarities, but in general, the procedure of obtaining a certificate of conformity consists of the following steps.
1. Select regulatory documents for product certification
To begin with, it is necessary to determine on the basis of which regulatory document (standard, regulation, directive) compliance with the requirements of your equipment will be confirmed. In case if the product does not fall under the directives, the marking cannot be applied.
For example, the requirements of the EMC-2014/30 / EC European Electromagnetic Compatibility Directive are referred to low-voltage complete devices). Only a document (certificate) issued by a notified European body based on an analysis of the technical information and test results can confirm compliance.
Low-voltage complete devices can be divided into 2 groups:
- with voltage up to 1 000 V;
- with voltage over 1000 V.
The requirements of the European Electrical Safety Directive LVD - 2014/35 / EU also apply to low-voltage complete devices with voltage up to 1 000 V. The new LVD directive does not require the issuance of a certificate of conformity, and all responsibility for conformity assessment lies on the manufacturer or his authorized representative in the European Union. The manufacturer or an authorized representative of the manufacturer should prepare and sign a declaration of conformity under his own full responsibility.
For example, Directive 2009/105/EC is suitable for simple pressure vessels. Gaseous fuel combustion devices (gas expenditure installations) fall under Directive 2009/142/EC. It should be noted that from 21.04.2018 this directive will be replaced by the Regulation (EU) 2016/426.
For new water boilers operating on liquid or gaseous fuels, it is necessary to comply with the requirements of Directive 92/42/ ЕЕС, which since September 25, 2013 has been replaced by Regulation (EU) No. 813/2013.
All medium and high voltage equipment (over 1000 V) is not subject to European directives, i.e., these products are not CE marked. Requirements for these products may also be regulated at the national level of the Member States of the European Union. In order to carry out the necessary tests and select suitable laboratories, first of all, it is necessary to build on the requirements for products that a particular potential buyer imposes, because in addition to government regulations there are individual customer requirements.
2. Determine if there are harmonized standards applicable to your product
Harmonized standards are certain European standards that flow from the directives of the new European Union approach. Standards refer to the same object, but are approved by different bodies. Their use is not always necessary, but applying harmonized EU standards makes it is easier to prove the compliance of products with safety requirements. There is a vast range of interrelated standards (European and domestic), where you need to select those that relate to your products.
To save time and effort, you can examine the competitors’ documents for similar products. Most likely, the major European manufacturers have already received all the necessary documents and did it correctly. Most often, the manufacturer publishes these documents on the website. If such information is not in public access, then you can introduce yourself as a potential client and request a commercial offer with a copy of certificates.
3. Define product certification procedure
In the European Union, product certification schemes are divided into modules. These modules can be found in Decision 768/2008/EC. This can be either self-declaration in conjunction with testing, or an inspection or audit of the quality management system by an Authorized Body; or a combination of both. The conformity assessment procedure varies depending on the type of product and the directive in accordance with which you will affix the CE mark.
4. Prepare the necessary package of documents
The manufacturer must have a prepared package of technical documentation. Requirements for documents depend on what kind of products you have; they are specified in the directive (often in its annexes), which regulates the certification of your goods.
For example, the Electromagnetic Compatibility Directive 2014/30/EC obliges technical documentation to include an assessment of product conformity with the requirements of the directive, including detailed design documentation (layouts and drawings, operating instructions, risk assessment documents, a list of applied EU directives and standards, laboratory test reports, etc.). Documents should also include a copy of the EC declaration of conformity, documents for serial production, tests, certificates, declarations, etc.
Basic requirements for the presence and storage of the document:
- in any form of confirmation of compliance, the correct set of documents is required according to EU requirements;
- this set of documents, as well as copies of technical documentation, is stored at both the manufacturer and its representative in the EU for 10 years after the last product has been released to the market;
- any inspection may be requested by the regulatory authorities, and the lack of full set of supporting documents may cause problems.
5. Submit documents to the notified body
The notified body is an organization that accepts and verifies documents for product certification and issues certificates. EU member states have several notified bodies on their territory; in CIS countries there are no notified EU bodies. The register of notified bodies is available on the BelGISS website.
It is forbidden to apply simultaneously to several notified bodies for carrying out the procedure of proving compliance.
If you fill out forms and documents incorrectly or your products receive critical quality marks, the notified body will refuse to issue a certificate, and re-submission of documents is possible in 3 months after you prove that you have corrected all the mistakes, therefore documents need to be treated responsibly from the outset.
6. Apply CE mark on the products
CE mark is the only EU conformity mark. The CE makes it clear to the EU supervisory authorities that products comply with European standards and directives and meet safety requirements.
Certification is a rather expensive process. Therefore, before deciding on the market you are going to enter, you should consider whether you are ready for the estimated costs.
The average cost of certification with tests according to the directive EMC 2014/30/EU is 3000 euros. The document confirming the compliance of products with the requirements is a type of product certificate. This certificate is issued only by a notified European body based on the technical information and test results.
The cost of electrical safety tests averages 1,500 euros. This is a test in an accredited European laboratory. The requirements of the new LVD directive (2014/35/ EU) for electrical equipment (powered by AC with voltage above 50 V and up to 1 000 V or from a direct current source with voltage from 75 V to 1 500 V) oblige to carry out tests in accredited laboratories.
Thus, if there are documents for all tests, the whole process of confirming compliance may take about a month. For more complex products, this period is extended to 6 months.
Medicine always remains in demand and at the same time it is developing rapidly. For the development of medical devices production, access to foreign markets is an excellent option. This idea is more and more popular in our country, because the expansion of sales markets contributes not only to the increase in the country's exports, but also strengthens the position of our companies on the international market. If the company does not set such a goal, then in the end it will just stagnate and will not be able to compete with the organizations of its business area.
Each manufacturer will undoubtedly know well their products, including the classification of medical devices. Depending on the type of product, different requirements apply. Herewith, there may be minor differences between them, so having missed something out in the beginning you can lose a lot of time, money and effort. Often, marketers can add quality words to packaging, but in the end they do not just make the product more attractive to consumers, but also increase additional costs dramatically.
For a start, let us sort out the groups of medical devices and the relevant Directives.
All medical devices are divided into the following groups:
- MDD medical products (starting from expendables such as bandages, dressings, catheters, and ending with products of complex technical design — ultrasound machines and inactive implants of teeth, breasts, etc.);
- products for in vitro diagnostics IVD (for in vitro diagnostics in laboratories or for self-use - test strips for glucose level, pregnancy tests);
- active implantable products AIMD (heart stimulants, artificial joints, etc.).
Currently, the following Directives are in force in EU legislation for these product groups:
- Council Directive 93/42/EC dated 14 June 1993 on the issue of medical equipment. Updated in 2007;
- Council Directive 98/79/EC dated 27 October 1998 on IN VITRO medical diagnostics devices;
- Council Directive 90/385/EC dated 20 June 1990 on active implantable medical devices. Updated in 2007.
In 2016, new versions of the Directive IVD 10618/16 and MDR 10617/16 were introduced, and since May 2017, the Directives have been implemented. Until 2020, a transition period is established, when two versions of the Directives are in effect, however, the notified bodies already have the right to require applicants to comply with the new provisions of the Directives.
All products are divided into several risk classes:
- 1 class — low risk medical devices;
- 2а class — medium risk medical devices;
- 2b class — increased risk medical devices;
- 3 class — high risk medical devices.
There are regulations that help to classify medical products.
For example, according to the lifespan of a medical product there are:
- short-term products (continuously used for no more than 60 minutes);
- medium-term products (continuously used for no more than 30 days);
- long-term (continuously used for more than 30 days).
According to the extent of invasiveness:
With an increase in the grade of classification, the risk class of the product also increases. The higher the risk class, the more stringent the requirements for the product are. Therefore, if the packaging with bandages is marked as «sterile», but it is not so, this, firstly, increases the risk of the product, secondly, increases the cost of obtaining permits for sale in Europe and, thirdly, changes the requirements and conditions imposed on the product.
In addition, with an increase in the risk class of a product, the area of responsibility of regulatory and legislative bodies also increases. For example, for products of risk class 2a and 2b only the notified body takes part in the inspection, and it gives a positive or negative conclusion on the issuance of the CE certificate of conformity. For risk class 3, even if the notified body gave a positive conclusion on issuing a certificate of conformity, the highest regulatory body — the Ministry of Health — may at any time withdraw a certificate after inspecting the documentation.
Stages of certification:
- at the first stage, it is advisable to certify the quality management system (according to ISO 9001 or ISO 13485). This enhances the image of the company supplying the product and increases the chance of unimpeded sale of products;
- then you need to find an authorized representative in Europe and sign a contract with him. The authorized representative will be fully responsible for your products;
- compile a technical file;
- double-check product instructions for compliance with the risk class, so that there are no unnecessary questions afterwards;
- double-check labels according to the requirements of the standard;
- revise the existing disinfection instructions, if necessary;
- submit all the above documents to the Ministry of Health of the country of the authorized representative. Documents are prepared by you and submitted by a representative.
It is very important to remember that all documents must be in English. However, the instructions and labels must also be in the language of the country in which the registration is carried out. If the manufacturer decides to prepare the documentation for certification independently, he may encounter a number of difficulties:
- first of all, not all notified bodies recognize the clinical studies conducted in Belarus, Russia. Some require testing in Europe, which involves unnecessary costs for the clinic, insurance, and the declaration of a product for clinical trials;
- secondly, «marketing mistakes» may occur in the instructions or on the label, which will increase the risk class of the product;
- thirdly, due to incomplete indication of information on the labels, there is also a risk of failing the certification procedure;
- mistakes in instructions for disinfection, namely, an indication of disinfectants of domestic origin, also lead to problems with obtaining documents;
- for products of risk class 3, Technical File instead of Design examination file is normally compiled;
- you can forget to send a component of a technical file to a notified body, so certification might also not be passed immediately;
- another difficulty is the legally illiterate contract with a European representative, where the full extent of his responsibility is not taken into account;
- manufacturers often fulfill the requirements of national standards and national legislation, but do not comply with more stringent European regulations.
These are the most frequent mistakes made by manufacturers that hinder supplies of products to Europe.
The production of building materials is one of the most developed industries in the world. Every day new constructions are erected, existing ones are being repaired and future ones are being designed. The quality of construction depends on the characteristics of building materials — from laying the foundation to finishing residential and industrial premises.
Construction products have their own specifics, since they are not used directly, but are included in construction works. In any country of the world, including the Republic of Belarus, the main responsibility for the safety of buildings and structures is borne by construction organizations — designers, architects, engineers, builders, workers who perform construction work using these materials, i.e. actually consumers of products, not its manufacturers. But in order to bear such responsibility, they must have reliable and complete information about the operational qualities of the product.
In Europe, main criteria for the release of products on the market is human security, as well as the load requirements, fire safety, hygiene and environmental protection, safety and ease of use, protection from noise, rational use of energy resources sustainable use of natural resources, reusability. Based on these principles, within the framework of European legislation, there are directives (analogous to the Technical Regulations of the CU) and other regulations aimed at protecting the consumer during the operation of a product. At the same time, regulations are much stronger legislation, as they are directly applicable. Moreover, the EU regulation is more important than the national legislation in a particular country. In the field of construction materials, the main document is EU Regulation 305/2011.
When certifying construction materials in Europe, the challenge is not to demonstrate compliance, but to ensure the stability of the declared product characteristics. It is necessary to prove that all manufacturing techniques are so solid that they allow to ensure this stability. That is why the manufacturer must take all necessary measures to ensure the accuracy of information about the technical characteristics of the products, as well as ensure their stability. For this purpose, various schemes of interaction with notified bodies are provided:
- scheme 1+ means that the notified body, after determining all the operating characteristics, periodically visits the production site, selects product samples to confirm the initially declared characteristics;
- scheme 1 means that after all the necessary tests, the notified body has no right to take additional samples for inspection;
- scheme 2+ means that the manufacturer provides in-plant control on his own (incoming raw materials, technological process, product quality), which guarantees the stability of product characteristics. The notified body confirms that in-plant control meets the necessary requirements;
- scheme 3 means the intervention of a notified laboratory that conducts all tests, and issues a test report, not a certificate;
- scheme 4 does not involve any third party interventions.
The process of testing products in an accredited European laboratory is very long and expensive. If you confirm the compliance of construction materials for getting the CE mark under scheme 1, then from the moment of filing the application to the moment of obtaining the certificate it takes at least 4 months on average.
Test reports drawn up on the basis of tests that were carried out by manufacturers’ own test equipment are recognized if the conformity assessment scheme 4 is specified in the harmonized standard. The main thing is to carry out tests on proven testing equipment.
Confirmation of compliance scheme 3 is moderate in terms of recognition, cost and timing. To understand how to test the products in an accredited European laboratory, you must execute the following sequence:
- find and study the appropriate harmonized standard;
- study the testing methodology for your products thoroughly;
- form samples according to the specified clauses in the above documents.
You can always ask for help from the laboratory itself. Consultation will be free.
In all cases, only after receiving a certificate of performance stability, the manufacturer can draw up a declaration, which gives the right to put the CE mark on the products.
EU Regulation 305/2011 replaces the previously applicable Directive 89/106/EEC. This regulation is at the same time simpler and more stringent. In addition, the regulation provides for a number of simplified procedures that will allow companies to reduce the costs of testing their products:
- the use of accumulated experience (if it is known, for example, that gypsum is not burning, then the manufacturer can declare this property of the product without testing);
- sharing test results (if two companies produce, for example, a brick of identical raw materials with the same equipment, the first company, after testing, can sell the test report of the second company). In this case, an official written contract is signed between the companies (certified by a notified body);
- cascading (if the product consists of various components whose suppliers have carried out tests, the manufacturer is not obliged to re-test them).
In the European Union countries, about 80% of all construction materials are subject to conformity. Of these, 70% are subject to confirmation of compliance in the form of CE marking in accordance with EU Regulation 305/2011 and harmonized standards (EN) for construction materials. As a result, 56% of all construction materials fall under EU Regulation 305/2011, which means it is necessary to obtain the CE mark for them.
In order to have an idea of whether CE mark is necessary for your products, you need to be well aware of harmonized EU standards, taking into account that there are more than 700 of them. Therefore, you can familiarize yourself with them and check your products on the NANDO website or use the services of appropriate specialists.
It should be understood that if your products are not subject to CE marking, for exporting to EU countries, construction materials must be evaluated for compliance with the national regulations of each of the countries to which products will be delivered. In this case, you do not get a CE mark.
Responsibility for violations in the process of conformity assessment and CE marking
In case of violations in the process of obtaining a CE mark (forging a mark, launching products on the market without a mark, etc.) for products subject to mandatory CE certification, according to Regulation 765/2008/CE and Decision 768/2008/CE, construction materials are derived from the EU market. At the same time, the form of penalty for violating the rules of CE marking is determined by the country to which these construction materials were delivered (from administrative liability in the form of a fine (2,000 euros and above) to criminal liability).
Basic requirements can be found in a harmonized standard. In the EU General Construction Regulation 305/2011 there are no requirements for an obligatory representative in the EU. Such requirements are usually noted in harmonized standards. If there are no such requirements in a standard, then a representative is not necessary. The technical file is an integral part of the production control system (PCS). You will not find the notion of a technical file in the EU General Construction Regulations 305/2011, but there are requirements for the PCS in some harmonized standards. Thus, the presence of a technical file is necessary to obtain the CE mark for certain construction materials.
Major difficulties in obtaining a CE mark for construction materials
- Production Control Systems (PCS) Audit
For many companies, PCS becomes a problem, since views on it in Europe are somewhat different from ours. Nevertheless, an audit can only be carried out by European authorities. In addition to the requirements themselves, this process is very expensive (over 1,500 euros in Lithuania, over 2,000 euros in the Czech Republic; and even more costly in other countries).
- Certification of personnel in Europe
Trained staff is an indispensable component of the production of quality products. To obtain a CE certificate for some construction materials, your staff will have to pass certification in Europe.
- Raw Material Documentation
Significant problems arise with the documentation for raw materials (for example, an indefinite sort of steel is used as a raw material, and so on). This documentation will be required. Accordingly, if you do not have such documentation, you will first have to obtain it.
- European technical regulations
You must have the necessary resource of European technical regulatory acts, and their cost also significantly hits the wallet if you don’t know where to get them.
Thus, certification of construction products in Europe can be simple, since many principles are based on reliability and experience of manufacturers who are ready to vouch for their products and take full responsibility for the nonconformity. On the other hand, this process may be very difficult because of many nuances associated with the use of materials directly in construction, not just for sale.
The most important characteristics of food products are its quality and safety. In today's world, food consumers have a wide choice and from a variety of food products they can choose those that, in their opinion, better meet the requirements of quality and safety. At the same time, manufacturers are trying to satisfy consumer demand by improving the quality control systems of their products.
Entering foreign markets, domestic producers are starting to take food safety issues more seriously.
The food industry in Belarus is one of the most strategically important sectors of the economy, which is constantly evolving and export-oriented. At the moment, entering new markets, including the European Union, is one of the country's priorities.
For a start, it is worth noting that food products are not obliged to CE certification. For example, you are going to deliver apples to Europe. In this case, the CE mark will not be affixed to all apples, because the mark can be applied only on labels, tags, packaging and/or containers in which products are delivered to the final consumer.
In the field of food production there are other schemes of certification and quality assurance. At the same time, these schemes are quite strict and serious, because we are talking about safety for human health.
The main document of the European Union in the field of food safety is Regulation No. 178/2002/EC.
This regulation is intended to establish general principles and requirements in food industry law, the general concepts of food industry in the EU, as well as to ensure a consistent approach to the development of the national food industry law of countries within the EU.
The regulation also establishes the European Food Safety Authority (EFSA, the European Union agency, which provides independent advice and information on existing and possible food industry related risks).
According to the Regulation No. 178/2002/EC, food products are substances or products that are, based on common sense, meant to be intended for human consumption in processed, partially processed or not processed form.
Food products include beverages, chewing gum, as well as all substances, including water, which are added to food products during their manufacturing and processing.
Food products do not include:
- pet food;
- live animals, if they are not prepared for human consumption;
- plants before harvest;
- medical products under the Directive 65/65/EEC and 92/73/EEC;
- cosmetic products under the Directive 76/768/EEC;
- tobacco and tobacco products under the Directive 89/622/EEC;
- narcotic and psychotropic substances under the UN Convention on Narcotic Drugs and the UN Convention on Psychotropic Substances;
- waste and contaminants.
Principles of food certification in the EU
Under this regulation there are basic principles:
Principle 1 — Risk Analysis. EU food law should be based on a risk analysis system. Under the risk analysis is meant the process, consisting of three interrelated stages:
- risk assessment (identification of hazards, their characteristics, assessment of manifestation, as well as risk characteristics);
- risk management (weighing all pros and cons of various possible solutions, taking into account risk assessment and, if necessary, choosing appropriate control measures);
- risk communication (an interactive exchange of information and opinions about hazards and risks between entities responsible for risk assessment and management, consumers, food industry enterprises, academia and other interested parties).
Principle 2 — Precautions. Sometimes, when there is a preliminary potential for adverse health effects, but this has not yet been confirmed by scientific data, temporary measures can be taken to manage the risk until further scientific information is available to conduct a broader assessment of this risk.
Principle 3 — Consumer Protection. The EU food legislation is aimed at protecting the interests of consumers and at giving them the opportunity to make competent choices regarding the products consumed. At the same time, any practice capable of misleading the consumer should be prevented.
Principle 4 — The Principle of Transparency. Regulation No. 178/2002/EC emphasizes the important role of public and non-governmental organizations, industry associations. In the development, evaluation and revision of food law open consultation with the public should be held.
Moreover, if there are reasonable grounds to suspect that a food product may pose a health risk, government agencies, depending on the nature, severity and extent of the risk, take appropriate measures to inform the public about this. All violations of food safety in Europe fall into the RAPEX system. RAPEX is a quick warning system for consumers about the potential danger of goods, with the exception of food, drugs, chemicals that fall under individual systems. The RAPEX system provides relevant authorities with operational information about hazardous products. Information on counterfeit and dangerous goods is regularly sent to a specially created Internet portal of the European Union, where the archive of the RAPEX system is located.
Before supplying products to the EU, it is necessary to decide, firstly, with the country of export, secondly, with a specific retailer / retail chain or end consumer. The fact is that the specifics of certification of food products depends on the country of delivery and on the requirements of a particular buyer / retailer. For example, the requirements of METRO, AUCHAN and other retail chains vary considerably both among themselves and across countries. In some chains, suppliers may be asked for BRC, in others for FSSC, and third — IFS. Plus there are specific standards for a particular country. The main problem is that there are no universal requirements. In order for the supplier not to fail, he needs to send an official request for certification requirements to a specific distribution chain of the country to which the delivery is intended, and only after receiving a formal response, take certification actions. Otherwise it will be a waste of time and money.
Certification schemes in the food industry
There are various certification schemes in the food industry. For example, BRC is a standard adopted by food manufacturers around the world, especially suppliers of British retailers.
A unified BRC standard consists of seven parts and imposes the following requirements on the manufacturer:
- adoption and implementation at the enterprise of the Hazard Analysis and Critical Control Point System (HACCP);
- availability of a documented and effective quality management system;
- control of production standards, products, processes and personnel.
A feature of the HACCP system is that with its help each stage in the production, storage and delivery of food is examined in detail, specific risks and hazards are identified, and effective methods of control and monitoring are implemented.
At the core of HACCP lie seven principles, the consistent implementation of which allows to develop and successfully manage the HACCP system in an enterprise:
- hazard analysis;
- the definition of Critical Control Points (CCP);
- definition of critical limits for each CCP;
- establishing a CCV monitoring system;
- the establishment of corrective actions;
- establishing a record keeping procedure;
- establishing procedures for checking the HACCP system.
FSSC 22000 is an international food safety management system of certification scheme, the requirements of which are based on:
- international standard ISO 22000:2005;
- HACCP principles;
- requirements for prerequisite programs, detailed in ISO/TS 22002-1:2009
IFS is a standard developed by the German and French federations of traders. The introduction of the standard is especially important for those manufacturers who are focused on cooperation with sellers of branded products, as well as their suppliers. The requirements of the standard are based on the principles of HACCP, GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice) and GHP (Good Hygiene Practice).
The stages of certification of food products in the EU:
- experts analyze and evaluate information about the product itself and the place of its production;
- the expert makes a trip to the site of the production;
- there is a selection of prototypes required for tests on the indicators stipulated by the Regulations and Procedures;
- the expert analyzes the production audit data and, in case of non-compliance of the processes with the Regulations, works out recommendations;
- conduct tests of selected samples in specially accredited laboratories;
- a certificate is issued for products, and it is registered in the EU Register.
The article was prepared on the basis of information provided by consulting company Easy Standard.
For a complete list of directives, standards and regulations that apply specifically to your product and the country of destination you need, contact Easy Standard for a free consultation.