Chemical industry

Scope of legal assistance

Entities representing chemical industry are among Clients of RGW.

We offer specialist legal assistance to the chemical industry taking into account sectoral regulations that are binding in this wide industry concerning various types of products and the method of their production.

RGW has extensive experience in the industry of plant protection products and fertilisers, which due to their significant role and scope of use are subject to special regulation and their production and introduction into the market require knowledge of a number of legal acts at the national and European level.

Area of activity

Registration of plant protection products

In Poland, as in all other Member States of the European Union, it is possible to place on the market plant protection products only ones that have been properly registered.

The registration processes of plant protection products has been regulated in detail in EU legislation and in national law.

RGW provides legal assistance regarding the registration process of plant protection products in particular through:

  • preparation of applications (in legal respect) for issuing an authorisation for placing on the market and use of plant protection products;
  • representation in the proceedings before the Minister of Agriculture and Rural Development regarding the issue of the authorisation for placing plant protection products on the market;
  • representation before the administrative courts in matters concerning the registration of plant protection products and placing them on the market;
  • preparation of legal opinions on the admissibility of placing plant protection products on the market on the territory of Republic of Poland;
  • analyses of the admissibility of placing active substances the territory of the European Union;
  • preparation of legal opinions on the admissibility of placing on the market plant protection products and active substances originating from countries that are not EU members.
The most important legal acts
Active substance
Registration process
The most important legal acts

The following legal acts have the fundamental meaning in the scope of the procedure for registration of a plant protection product:

  • Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC;
  • Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation  (EC) No 1907/2006;
  • the Act of 8 March on plant protection products.
Active substance

Only active substances approved by the European Commission may be used in production and placed on the market within European Union.

Active substances, are substances, including micro-organisms, showing general or specific effects on harmful organisms or on plants, parts of plants or on plant products.

An active substance may be approved only if in the light of current scientific and technical knowledge, it an be expected that taking into consideration criteria for approval of plant protection products containing this substance meet, inter alia, the following requirements:

  1. residues of plant protection products resulting from the use consistent with good practice of plant protection and taking into account realistic conditions of use:
  • they do not have any adverse effect on human health;
  • they have no unacceptable effect on the environment.

2. plant protection product applied in a manner consistent with good practice of plant protection and having regard to realistic conditions of use:

  • is sufficiently effective;
  • has no immediate or delayed adverse effect on people’s health;
  • has no unacceptable effect on plants and plant products;
  • does not cause any unnecessary suffering and pain to vertebrates that are subject to control;
  • has no unacceptable effect on the environment.

The procedure for the approval of active substances used in plant protection products takes place on the European level and takes between 2.5 to 3.5 years. The first approval is granted for the period of not exceeding 10 years.

Registration process

Plant protection product must be approved in an appropriate domestic procedure before it is introduced in a given country.

The competent authorisation authority for placing plant protection products in Poland is the Ministry of Agriculture and Rural Development.

The plant protection product may be authorised only if the applicant shows that the product meets rigorous criteria.

The authorisation indicates i.a.

  • identification of plants or plant products and areas not related to agriculture on which the plant protection product may be used;
  • purposes for which the product can be used;
  • requirements for placing the product on the market and the use of the product;
  • validity period of authorisation which cannot be longer than one year from the date of expiration of validity of approval of active substances, safeners and synergists contained in a given plant protection product.

A Member State examining the applications shall decide within twelve months whether the requirements concerning the permit have been met. However, this period is often prolonged or suspended due to, for example, the need for the authority to obtain additional information or to carry out a procedure for testing the equivalence of active substances. 

Labelling and advertising

Due to the risks connected with the improper use of plant protection products, the legislator has introduced a number of restrictions on the advertising of plant protection products as well as obligations regarding the proper packaging and labelling of such products.

RGW provides legal assistance in the above-mentioned scope in particular by:

  • preparing legal opinions on the correctness of packaging and labelling certain plant protection product;
  • preparing legal analyses concerning the admissibility of using certain marketing measures in relation to plant protection products;
  • defence in criminal proceedings concerning the use of improper packaging and incorrect labels;
  • representing party in administrative proceedings concerning the imposition of a sanction fee for advertising a plant protection product in an unlawful manner.

Packaging and labelling obligations

  • plant protection products must be packed in such a way as to reduce the likelihood of such a mistake being made as much as possible;
  • plant protection products must contain ingredients that discourage or prevent consumption;
  • unit packaging of plant protection products placed on the market should be tightly sealed and undamaged, provided with an approved label in Polish and meet requirements set out in authorisation for placing plant protection product on the market or parallel trade permit;
  • plant protection products’ labels should meet all criteria and contain all information required by law.

It should be noted that before issuing an authorisation, Member States can require the submission of sample copies or packaging designs as well as designs for labels and leaflets which in practice turns out be be the rule.

Penal sanctions:

The Polish legislator has introduced a catalogue of offences connected with improper labelling and packaging of plant protection products. The most important prohibited acts in the above-mentioned scope include:

  • placing on the market plant protection product in unit packaging not compliant with the requirements of the law;
  • selling a plant protection product or making an offer of selling such a product in a replacement packaging.

The above-mentioned offences are punishable by a fine.

Obligations and sanctions concerning the advertising of plant protection products

  • plant protection products which did not obtain an authorisation cannot be advertised in any way;
  • every advertisement of a plant protection product should contain clear and legible label saying: “Use plant protection products safely. Read the information on the label and product information before each use.”;
  • it is acceptable to replace the term “plant protection product” with more precise product term, such as “fungicide”, “insecticide” or “herbicide”;
  • advertisements must not contain information that would be misleading in relation to possible risks to human, animal or environmental health;
  • Member States may prohibit or restrict advertising products in certain media;
  • advertisements must not visually present any potentially dangerous practices (e.g. use near food, use without appropriate protective clothing);
  • advertisements should pay attention to proper phrases and warning symbols placed on labels.

Manufacturing, confection, distribution

Business activity in the field of production, confection and distribution of plant protection products is a regulated activity.

RGW provides legal assistance related to production, confection and distribution of plant protection products i.a. by:

  • preparing legal opinions on the need to obtain an entry in the register of entrepreneurs performing activity within the scope of placing plant protection products on the market or confectioning those products;
  • conducting an audit in the field of compliance of entrepreneur’s activity with the relevant provisions concerning production, confection and distribution of plant protection products;
  • drafting contracts concerning production, confection and distribution of plant protection products taking into account relevant provisions;
  • representing parties in registration proceedings as regards entry into an appropriate register;
  • representing in proceedings before competent authorities concerning sanction fees connected with placing on the market or confectioning plant protection products;
  • representing before administrative courts in cases concerning sanction fees connected with activity on the plant protection products’ market;
  • defence in criminal proceedings concerning placing on the market or confectioning plant protection products or active substances

Obligation to enter in the register

Activities in the field of placing plant protection products on the market or confectioning are regulated activities and require an entry in the register of entrepreneurs conducting activity in the field of placing plant protection products on the market or confectioning of these products.

The producer of plant protection product is not subject to entry in the register if he obtained authorisation to place particular plant protection product on the market. However, if this producer conducts business activity in the field of selling plant protection products to the final purchaser, this activity requires an entry in the register.

The authority keeping the above-mentioned register of entrepreneurs is:

  • voivodeship inspector competent for the place of resident or registered office of the entrepreneur, except that if the entrepreneur is a natural person – the place of conducting business if it is different from the person’s place of residence;
  • voivodeship inspector competent for the planned place of business, to which an application for entry in the register was submitted.

Most important obligations

The basic obligation of all entrepreneurs operating in plant protection products industry is to place on the market only plant protection products authorised for marketing in particular country, in original, undamaged and properly labelled packaging.

Entrepreneurs operating in the field of production, confectioning or distribution of plant protection products are obliged in particular to:

  1. ensure that persons selling plant protection products to the final purchaser:
  • completed training;
  • provided the purchaser of plant protection products, at his request, with information on the risks connected with using purchased plant protection products and on their correct and safe use;
  1. ensure that persons other than the final purchaser have the possibility of ongoing consultation with the person possessing the above-mentioned qualifications;
  2. store plant protection products which have expired or for other reasons are not intended for sale, in a separate and properly marked place;
  3. fulfilling obligations in the field of keeping and storing documentation required by law;
  4. placing relevant information in offers for the distant sale of plant protection products.

Sanctions

In order to secure compliance with the obligations imposed on entities conducting activities in the field of production, confection and distribution of plant protection products, the legislator introduced a number of penal provisions. The behaviours, such as the following, are prohibited:

  • placing on the market of seed treated with a plant protection product in breach of statutory requirements;
  • placing on the market of a plant protection product after its expiry date or in breach of other statutory requirements;
  • failure to ensure that persons selling plant protection products to the final purchaser have appropriate;
  • not storing plant protection products which have expired or for other reasons not intended for sale in a separate and properly marked place;
  • sale of plant protection products indicated for professional users who do not meet statutory criteria;
  • selling or making offer for the sale of plant protection products to a person whose behaviour indicates that he is intoxicated or to a minor;
  • selling or making an offer for the sale of plant protection products in a replacement packaging;
  • selling or making an offer for the sale of plant protection products indicated for professional users in a room where food or feed is sold;
  • selling or making an offer for the sale of plant protection products using automatic machine, self-service or sale outside the settled location.

The above-mentioned prohibited acts constitute offences punishable by a fine. 

Parallel import

Due to the fact that the basic procedure of registration of plant protection products is long and very complicated, the EU legislator has provided for a simplified procedure for authorising and placing plant protection products on the market under parallel import (trade).

RGW in the field of parallel import offers, i.a.:

  • preparation of applications (in legal scope) for issuing the authorisation for parallel trade of particular plant protection product;
  • representation of entities interested in obtaining the authorisation for parallel trade in proceedings before the Minister of Agriculture and Rural Development;
  • representation of a party before administrative courts in cases concerning application for a parallel trade authorisation;
  • preparation of legal analyses regarding the possibility of applying for authorisation for parallel trade in relation to a specific plant protection product.

Registration under parallel trade takes place in administrative proceedings conducted by the competent authority of a Member State. In Poland, the competent authority, as in the case of the basic procedure, is Minister of Agriculture and Rural Development.

Obtaining the authorisation for parallel trade is possible when the following conditions are met:

  • the product to which the application refers was authorised in one of the Member States (in the so-called home Member State);
  • the composition of the product to which the application refers is identical to the composition of the product (the so-called reference product) authorised previously in the country in whose territory the product to which the application refers is to be introduced (Member State of introduction).

A plant protection product shall be considered as identical to the reference product if:

  • they were manufactured by the same enterprise or by enterprise associated or under a license according to the same production process;
  • they are identical in terms of specification and content of the substance;
  • they are the same or equivalent in terms of contained ingredients.

In principle an authorisation for parallel trade should be grated within 45 working days of the receipt of a complete application by the competent authority. In practice, due to the need to exchange information concerning product being subject to the proceedings between Member States, this term is usually extended. 

Unfair competition and anti-monopoly law

Due to the technological advancement of the sector of plant production products and fertilizers and very high expenditure incurred by industry entrepreneurs on research and development, protection against unfair competition, especially in the field of protection of business secrets, is of a particular importance.

RGW provides legal assistance in the above-mentioned field in particular through:

  • preparing legal opinions on the possibility of classifying certain behaviours as acts of unfair competition;
  • conducting a comprehensive audit regarding the use of appropriate safeguards against the effects of acts of unfair competition;
  • preparing legal analyses and recommendations regarding the protection of business secrets;
  • representing a party in civil proceedings concerning claims related to acts of unfair competition;
  • representing the injured entity in criminal proceedings, at the stage of preparatory as well as judicial proceedings;
  • drafting contracts and annexes having regard to protection against acts of unfair competition (license agreements, contractual penalties, confidentiality clauses etc.) taking into account the specificity of the chemical industry.

 

Acts of unfair competition
Remedies for injured entrepreneurs
Acts of unfair competition

An act of unfair competition is any act that is contrary to the law or good practices if it threatens or violates the interest of other entrepreneur or customer.

The above-mentioned general clause allows for a flexible assessment of entrepreneurs’ behaviour which can be detrimental to the fairness of competition and to use appropriate  civil law measures to the torts found.

Regardless of above, the legislator included in the Act on combating unfair competition, a number of the so-called named acts, i.e. civil law torts specified directly by legislator.

In the chemical industry, the protection against the below has a significant meaning:

  • acts of unfair competition aimed at unlawful use of the reputation of another entrepreneur (e.g. unlawful use of a firm, name, symbols, entrepreneur’s surname, geographical or regional names);
  • acts of unfair competition aimed at damaging the competitor’s reputation (e.g. dissemination of false or misleading information about a competitor’s enterprise, people managing it, goods produced or services rendered, prices and economic and legal situation);
  • unlawful use of business secret (e.g. takeover of the technology for the production of specific products, theft of formulas of substances produced, unlawful use of detailed information concerning production process, lists of contractors, information on orders etc.);
  • placing on the market of counterfeit products (described in detail below in the “Counterfeit products” section).

  

Remedies for injured entrepreneurs
Civil law

 In the event of act of unfair competition, an entrepreneur whose interest has been threatened or infringed may request:

  • that the illegitimate actions be ceased;
  • removing effects of illegitimate actions;
  • making a single or multiple declaration of an appropriate content and in an appropriate form;
  • that the damage be remedied in accordance with general principles;
  • returning of benefits obtained groundlessly in accordance with general principles;
  • awarding an appropriate amount of money for a specific social purpose connected with supporting of Polish culture or protecting of national heritage – if an act of unfair competition was culpable.

Claims related to acts of unfair competition are barred by statute of limitations after three years, and the limitation period begins separately for each infringement.

Criminal law

 Offences of unfair competition are subject to a fine, the penalty of restriction of liberty or penalty of deprivation of liberty for up to 2 years. The offence of organising or directing the system of pyramid selling is punishable by the penalty of deprivation of liberty from 6 to 8 years.

Petty offences are punishable by arrest or fine.

Indicated offences and petty offences are prosecuted only at the request of injured entity.

Counterfeit products

A characteristic feature of the market of plant protection products as well as fertilizers is the large scale of the phenomenon of placing counterfeit products or fertilizers on the market.

In this area, RGW has also extensive experience and offers wide range of legal services such as:

  • legal representation in civil law matters related to placing on the market non-original products;
  • preparation of legal opinions on lawfulness of placing on the market certain products;
  • representation of the injured entity in criminal proceedings. both in preparatory and judicial proceedings;
  • preparation of legal opinions on agreements concluded by entrepreneurs, having regard to prevention in the field of placing counterfeit products on the market;
  • preparation of notifications to competitive administrative authorities regarding suspicions concerning placing counterfeit products on the market;
  • defense in criminal proceedings concerning placing counterfeit plant protection products or fertilizers on the market.
Remedies for entrepreneurs
Administrative law sanctions
Remedies for entrepreneurs

For entrepreneurs whose interests have been violated in connection wiith placing on the market non-original products, the possibility of protecting right under available civil and criminal measures is of a particular importance.

The basic regulations in this respect can be found in the Act on combating unfair competition, which also in the case of placing on the market counterfeit products provides both private and public law protection measures.

Civil measures

According to the Act of combating unfair competition, an act of unfair competition is i.a.:

  • such designation of goods or services, or the lack thereof, which may mislead customers as to the origin, quantity, quality, ingredients, way of manufacturing, suitability, applicability, repair, maintenance or other significant features of goods or services as well as concealing the of the risks that involves using them;
  • placing on the market goods in packaging which can cause the effects referred to above.

If an entity commits an act of unfair competition, the injured entity may exercise all the rights granted to it by the Act on combating unfair competition, which are detailed above in the section “Unfair competition in the chemical industry”.

 

Penal measures

 No less important for injured entrepreneur may be punitive repressive measures applicable to the dishonest entity.

Pursuant to the Act of combating unfair competition, a person who, by using technical means of reproduction, copies external form of a product or places copied product on the market, thus creating the possibility of misleading customers as to the identity of the producer or product, which causes serious damage to the entrepreneur, is subject to a fine, punishment of restriction of liberty or imprisonment for up to 2 years.

The offence is not prosecuted ex officio and requires that injured person files a motion to prosecute.

Administrative law sanctions

It should be remembered that the authorisation for placing certain plant protection product on the market is always issued to a specific entrepreneur. Placing counterfeit product, even if its composition is identical to the original product, is in fact placing on the market product without authorisation within the meaning of the relevant provisions.

 

According to the Act on plant protection products, an entity that sells a plant protection product without the required authorisation to place it on the market or a parallel trade permit, is obliged to pay a sanction fee in the amount of 200% of the value of plant protection products sold according to their selling price.

Use of chemical products

The use of plant protection products, just as production and distribution, is subject to  numerous prohibitions and orders. Failure to comply with legal requirements in this respect may result particularly in criminal and civil responsibility. Incorrect use of plant protection products can lead to, for example, material damage.

In the field of using plant protection products, RGW provides legal assistance in particular by:

  • preparing legal opinions on the compliance of a specific manner of dealing with plant protection products with the Act on plant protection products and the Environmental Protection Act;
  • conducting a comprehensive audit regarding the compliance of using plant protection products by entrepreneur with law;
  • preparing legal analyses regarding possible claims for incorrect use of plant protection products;
  • representing parties in court proceedings in connection with claims for damages resulting from improper use of plant protection products;
  • defence in criminal proceedings concerning liability for improper use of plant protection products.
Use of products intended for professional users
Obligations and sanctions regarding the use of plant protection products
Use of products intended for professional users

The act on plant protection products introduces a number of requirements for people using plant protection products intended for professional users.

Professional users are natural persons who use plant protection products for purposes other than their own non-profit needs, in particular in the context of economic of professional activities, including in agriculture and forestry.

Obligations and sanctions regarding the use of plant protection products

The Act on plant protection products contains a wide catalogue of prohibited acts regarding the use of products, such as:

  • use of plant protection products after the expiry date or contrary to other statutory requirements;
  • performing plant protection treatments using a plant protection product that cannot be used in accordance with the provisions of the law;
  • use of plant protection products not in accordance with the requirements included in the label;
  • use of plant protection products in a manner that endangers human health, animals or the environment;
  • storing or disposing of plant protection products in a manner that endangers human health, animals or the environment;
  • using or disposing unit packaging for plant protection products in manner that endangers human health, animals or the environment;
  • not using integrated pest management by a professional user of plant protection products
  • not keeping documentation showing the manner of implementing requirements of integrated pest management by professional user of plant protection products;
  • using plant protection products with the use of agricultural aviation equipment, the use of which is prohibited with this equipment;
  • performing treatments with the use of plant protection products using agricultural aviation equipment without notifying to the voivodeship inspector about such intention;
  • performing treatments with the use of plant protection products using agricultural aviation equipment, contrary to the prohibition to perform the treatment;
  • using plant protection products with the equipment intended for the use of plant protection products, which is technically defective or uncalibrated and evading the obligation to test the equipment to confirm its technical efficiency;
  • using seed treated with a plant protection product for purposes other than sowing or planting;
  • not keeping records of treatments using plant protection products within the time limit specified in the Act.

The above offences are punishable by a fine.

Organic farming

In recent years, organic farming is a dynamically growing sector of farming throughout the European Union.

RGW provides legal assistance to entrepreneurs operating in chemical and agricultural industry, in particular in the field of:

  • preparing legal opinions on the possibility of using certain fertilisers and plant protection products in organic farming;
  • conducting a comprehensive audit regarding the compliance of entrepreneur’s business activity with the provisions concerning organic farming;
  • representing parties in administrative proceedings concerning imposition of a financial penalty in accordance with the Act on organic farming;
  • representing in registration proceedings concerning specific substances, both in the proceedings based on general principles and before competent assessment bodies;
  • preparing analyses and recommendations regarding the application of specific legal solutions aimed at protecting business secrets.
Basic legal regulations in organic farming
What is organic farming?
Marketing of products intended for use in organic farming
Basic legal regulations in organic farming
  1. Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91
  2. Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control
  3. Act of 25 June 2009 on organic farming
  4. Regulation of the Minister of Agriculture and Rural Development of 2 March 2010 concerning organisational units assessing and confirming the compliance of products for organic farming with the requirements set out in the regulations on organic farming and keeping a register of these products.
What is organic farming?

Organic farming is a general farm management and food production system combining:

  • practices that are most advantageous for the environment;
  • high level of biodiversity;
  • protection of natural resources;
  • applying high animal welfare standards;
  • production method meeting requirements of some consumers preferring products manufactured using natural substances and natural processes.
Marketing of products intended for use in organic farming

In organic farming, certain products and substances can be used as plant protection products or fertilisers only after obtaining the authorisation of the European Commission in a special procedure and including a specific product or substance in the closed register.

However, even products and substances listed in this closed register require separate approval under general principles in each Member State, in accordance with relevant EU and national legislation.

After being authorised for general agriculture, certain product or substance, if it is listed in the closed register of products authorised by the European Commission, may be formally placed on the market as a product intended for use in organic farming.

Before commencing the placing on the market specific plant protection products or fertilisers intended for use in organic farming, however, it is reasonable to obtain confirmation of compliance of a given substance or products with the requirements in this respect by the so-called organisational units assessing and confirming the compliance of products for organic production.

Minister of Agriculture appointed in Poland as assessment units i.a.:

  • Institute of Soil Science and Plant Cultivation – State Research Institute in Puławy – for organic fertilisers, mineral fertilizers, organic-mineral fertilisers and products improving soil properties for organic production;
  • Institute of Plant Protection – National Research Institute in Poznań – for plant protection products for organic production.

The research units confirm the compliance of products and substances with legal requirements and also keep registers of these products and substances.

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