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The General Product Safety Regulation (EU) 2023/988 (GPSR) applies across the European Union since 13 December 2024, replacing the old 2001 directive. We have discussed it in October last year here. In brief, the GPSR reshapes how companies must handle product safety, traceability, and labeling for all non-food consumer products.


The provisions of the GPSR refer to several key operators throughout the supply chain, amongst which the four main players: manufacturers, importers, authorised representatives, and distributors. The aim of this article is to discuss the meaning that the GPSR gives to each of these concepts and the attributes/responsibilities attached to each of them. In practice, knowing one’s legal responsibilities (and attached liabilities) makes a real difference and could mean the difference between compliance and non-compliance (with all ancillary consequences).


1. Manufacturer


As per the GPSR, the manufacturer is “any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under that person’s name or trademark”.[1] 


The manufacturer has the following key obligations:[2]

  • To ensure the product is safe and complies with all applicable EU rules.

  • To carry out (or have carried out) a risk assessment and, if required, testing.

  • To label the product with: (i) a product identifier (type, batch, or serial number); (ii) the manufacturer’s name, registered trade name or trademark, and contact address (postal and electronic); (iii) to provide instructions and safety information in a language understood by consumers in the target EU country; (iv) to keep technical documentation and records of complaints or recalls for 10 years; (v) to take corrective action — including recalls — if a product is unsafe.


Note that if an economic operator (such as a distributor – see below) rebrands or substantially modifies a product made by someone else, they legally become its manufacturer under the GPSR.[3]


2. Importer


An importer is “any natural or legal person established within the Union who places a product from a third country on the Union market.”[4]


The importer has the following key obligations:[5]

  • To verify that the manufacturer has done their job: risk assessment, labeling, safety information, and documentation.

  • To place their own name, trade name or trademark, and contact address (postal and email) on the product, its packaging, or accompanying documents.

  • To ensure the product can be safely used and that it complies with the GPSR and any specific product legislation.

  • To cooperate with market surveillance authorities and keep documentation for at least 10 years.


If the manufacturer is located outside the EU, the importer becomes the main contact point for authorities and consumers inside the EU.


3. The Authorised Representative — The Local Contact for Non-EU Manufacturers


The authorised representative is “any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on that manufacturer’s behalf in relation to specified tasks with regard to the manufacturer’s obligations under [the GPSR].”[6]


In other words, a manufacturer outside the EU can appoint an authorised representative within the EU to act on their behalf. This is common when non-EU companies want to sell directly into the European market without setting up a legal entity.


The authorized representative has the following key obligations:[7]

  • To hold the EU declaration of conformity or technical documentation for inspection.

  • To cooperate with authorities on safety matters.

  • To communicate with market surveillance bodies on behalf of the manufacturer.


However, the authorised representative cannot replace the manufacturer’s core responsibilities — they assist, but they don’t assume full product liability unless they also act as importer or distributor.


4. Distributor — The Link in the Chain


The distributor is “any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.”[8]


In other words, a distributor is any operator in the supply chain who makes a product available on the market — for example, a retailer or wholesaler — without being the manufacturer or importer.


The distributor’s key obligations are the following:[9]

  • To check that the product bears all required labeling, including manufacturer/importer details and instructions.

  • To ensure the product is not clearly unsafe before sale.

  • To keep records of suppliers and customers to ensure traceability.

  • To cooperate with authorities in case of safety investigations or recalls.


5. Why These Distinctions Matter


The definitions and concepts referred to above aren’t just labels — they essentially allocate liability to various operators throughout the supply chain. In plan words, they indicate who’s accountable when something goes wrong with respect to a non-food product.


Examples of this allocation of liability may include the following situations:

  • If a product lacks contact details or traceability, authorities will hold the importer responsible.

  • If an unsafe product is found, the manufacturer must initiate corrective actions.

  • If the manufacturer is a company located outside the EU, and there’s no EU importer, the authorised representative may be treated as the responsible person.


Also, gaps in compliance, may lead to a product being stopped from being legally sold in the EU.


Conclusion


For businesses, understanding the concepts outlined by the GPSR means knowing exactly which role they play, ensuring the right information is on product labels, and keeping the proper documentation in place. In real life, reaching such conclusion often starts with a simple question: “what should the label contain?” Hopefully, this question is addressed to a lawyer.


[1] GPSR, Art. 3 para. (8).

[2] Ibid, Art. 9.

[3] Ibid, Art. 13.

[4] Ibid, Art. 3 para. (10).

[5] Ibid, Art. 11.

[6] Ibid, Art. 3 para. (9).

[7] Ibid, Art. 10.

[8] Ibid, para (11).

[9] Ibid, Art. 12.


Truth is agency agreements are used very often in a business context, as if these are the simplest agreements in the world. In a sense they are, in another – they hide some pitfalls which should probably be flagged more often. The more popular they are, the more people think “it’s no big deal”, just go ahead and sign already.


First of all, with the risk of sounding a bit silly, agency agreements need to be agency agreement, namely: (i) the agent needs to act upon the direction and instruction of the principal; (ii) the agent needn’t bear any financial or commercial risk resulting from their activity with the principal; (iii) there needs to be dependency between the two. Any deviation from these key points leads to the so-called “agency-washing”[1] hybrid models; in other words, agreements that are not really agency agreement, but actually distribution agreements or alike.


Why does this matter anyway?


It matters at least from a competition law perspective. Given the dependency between the agent and the principal, agency agreements are not considered to be agreements which may trigger the distortion of competition – the principal and agent act as one. Hence, they are not caught by Art. 101(1) TFEU (or the relevant national law provisions covering the same scope) which forbid agreements between undertakings  which would harm competition.


The EC Guidelines on the topic provide that “(12) An agent is a legal or physical person vested with the power to negotiate and/or conclude contracts on behalf of another person (the principal), either in the agent's own name or in the name of the principal, for the: purchase of goods or services by the principal, or sale of goods or services supplied by the principal. (13) The determining factor in defining an agency agreement for the application of Article 101(1) is the financial or commercial risk borne by the agent in relation to the activities for which it has been appointed as an agent by the principal. In this respect it is not material for the assessment whether the agent acts for one or several principals. Neither is material for this assessment the qualification given to their agreement by the parties or national legislation.[2]


Adopting hybrid models, whereby the agent is acting more like an independent distributor brings about the need to assess whether in fact the hybrid agency agreement contains some provisions which may trigger competition law issues such as market sharing aspects, prohibition of sales, non-compete etc. This is because, if an agreement fails to meet the features of a genuine agency agreement, it will likely be considered to be a distribution agreement, subject to the prohibition included in Art. 101(1) TFEU (and the national provisions covering the same scope).


One additional practical question: what if the agent/distributor is a freelance natural person? Then there are some tax/labour related considerations for which you would want the guy or girl to be considered independent. Well then – they need to be independent in terms of working hours, leave etc., but they need to follow the principal’s instructions should they want to be qualified as agents.


In this case, business needs to decide: do we want an agent (in the real sense of the word) or do we want a distributor (that may sometimes follow our direction)? Who knows? Please only be compliant when deciding


[1] “Agency washing” is a term not used officially by the European Commission, but it appears as such in less formal discussions.

[2] EC Guidelines on Vertical Restraints, OJ C 130, 19.5.2010, pp. 1–46.


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The Competition Council has adopted the long-awaited Guidelines on foreign investment notifications (“the Guidelines”)[1]. The final version follows the draft published by the Competition Council this spring, which we covered in detail here.


The Guidelines largely reflect the content of the draft; unfortunately, however, they do not clarify a number of aspects that have proven unclear in practice. Below, we have summarized in a table what the draft provided, what the Guidelines set out, and our comments - my two cents – on the additions.


Happy reading!

Draft

Guidelines

Our comments

 

Art. 1 – The purpose of these Guidelines is to provide guidance on the method of calculating the value of an investment, as well as on matters related to the submission of the notification and the notion of control under Government Emergency Ordinance No. 46/2022 on the measures for implementing Regulation (EU) 2019/452 of the European Parliament and of the Council of 19 March 2019 establishing a framework for the screening of foreign direct investments into the Union, as well as for amending and supplementing Competition Law No. 21/1996, with subsequent amendments and completions, hereinafter referred to as “GEO No. 46/2022.”

Art. 1 – (1) The purpose of these Guidelines is to provide guidance on the method of calculating the value of an investment, as well as on matters related to the submission of the notification and the notion of control provided for in Government Emergency Ordinance No. 46/2022 on the measures for implementing Regulation (EU) 2019/452 of the European Parliament and of the Council of 19 March 2019 establishing a framework for the screening of foreign direct investments into the Union, as well as for amending and supplementing Competition Law No. 21/1996, approved with amendments and completions by Law No. 164/2023, with subsequent amendments and completions, hereinafter referred to as “GEO No. 46/2022.”

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(2) The rules provided in these Guidelines are aligned with the other conditions established by GEO No. 46/2022 so that a foreign direct investment, a new investment, or an investment from the European Union is subject to review and approval by the Commission for the Examination of Foreign Direct Investments, hereinafter referred to as CEISD. [2]

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Art. 2 – The threshold referred to in Article 3(1)(b) of GEO No. 46/2022, representing the value of the foreign direct investment, new investment, and investment from the European Union subject to review and approval by CEISD, is determined in accordance with the rules set out in this chapter.

Art. 2 - The threshold established in Article 3(1)(b) of GEO No. 46/2022, representing the value of a foreign direct investment, a new investment, and an investment from the European Union subject to review and approval by CEISD, is determined in accordance with the rules set out in this chapter.

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Art. 3 – (1) The value of the investment is represented by the value of the funds made available by the investor.

(2) Funds represent the total amount of all consideration that has been or will be provided in the context of the investment by or on behalf of the investor who is a party to the transaction, including payments by cashless payment instruments, tangible or intangible assets, shares or transfers of ownership, debt remission, offsets, services, or any other in-kind consideration.

Art. 3 – (1) The value of the investment is represented by the value of the funds made available by the investor.

(2) Funds represent the total amount of all consideration that has been or will be provided, directly or indirectly, in the context of the investment by or on behalf of the investor who is a party to the transaction, including payments through cashless payment instruments, tangible or intangible assets, shares or transfers of ownership, debt remission, offsets, services, or any other in-kind consideration.

The Guidelines adopt the provisions of the draft verbatim. The wording is of a “cover all” type.

Art. 4 – (1) The value of the investment is determined as follows:

Art. 4 – (1) The value of the investment is determined as follows:

 

a) In the case of investments made through the acquisition of equity interests – representing shares or social parts – the value of the investment is determined by taking into account the price paid for the equity interests and/or the capital made available by the investor, as applicable.

a) In the case of investments made through the acquisition of equity interests – representing shares or company stakes – the value of the investment is determined by taking into account the price paid for the equity interests and/or the capital made available by the investor, as applicable;

The Guidelines retain the provisions from the Draft according to which, in the case of an investment made through the acquisition of shares or company stakes, the value of the investment is determined with reference to the price or the capital made available by the investor.

The concept of “price” is clear. “Capital made available by the investor” could likely encompass a broader range, potentially including assets – for example, in a joint venture where the investor contributes real estate. We believe, however, that a clearer formulation would have been useful.

b) In the case of acquiring equity interests through a capital increase or any other form of contribution to the share capital, which does not involve the transfer of existing equity interests, the value of the investment consists of the total value of the contribution, including both the nominal value of the subscribed shares and the share premium.

b) In the case of acquiring equity interests through a capital increase or any other form of contribution to the share capital, which does not involve the transfer of existing equity interests, the value of the investment consists of the total value of the contribution made, including both the nominal value of the subscribed shares and the share premium, if applicable. For clarity, the scenario of acquiring equity interests through a capital increase or any other form of contribution to the share capital refers to a situation in which there is a change in the structure of shareholding or ownership, either through the entry of a new partner or shareholder, or through a change in control or management. In this regard, a capital infusion or any other form of contribution to the share capital made by an existing partner or shareholder without changing control or management does not constitute a foreign direct investment, nor an investment from the European Union, according to the provisions of GEO No. 46/2022.

The clarification that only a change in the ownership structure triggers the notification obligation is welcome.

 

On the other hand, we believe that this clarification should also be nuanced to cover particular situations, such as when the investment must still be notified if the capital increase leads to a change in ownership, but the new partner/shareholder has the same UBO as the existing partners/shareholders (in other words, there is no real change in control).

 

Reading the text, one can conclude that the notification obligation is not triggered solely by a change in control, but merely by a change in shareholding, without a real impact on the company’s control.

c) In all other cases of investments that do not involve the payment of a price, the value of the investment is determined as the market value of the acquired equity interests/assets, established based on the acquirer’s own valuations prepared for the purpose of the relevant transactions.

c) In all other cases of investments that do not involve the payment of a price, the value of the investment is determined as the market value of the acquired equity interests/assets, established based on the acquirer’s own valuations prepared for the purpose of the relevant transactions. The valuation prepared by the acquirer is determined based on the market value, the book value, or the value used for tax purposes, in that order, depending on the availability of each value, or valuation reports may be used to determine the value of the investment.

A welcome clarification.

2) If the acquisition of equity interests or assets is carried out in a mixed manner, by combining some of the methods provided in paragraph (1), the value of the investment is represented by the total invested capital, determined according to the rules applicable to each of the operations.

(2) If the acquisition of equity interests or assets is carried out in a mixed manner, by combining some of the methods provided in paragraph (1), the value of the investment is represented by the total invested capital, determined according to the rules applicable to each of the operations.

Ibid.

(3) In cases where the consideration consists of other assets, services, interests, or other in-kind consideration, their value is their fair market value on the date the parties submit the authorization request.

(3) In the event that the consideration consists of other assets, services, interests, or other in-kind contributions, their value is their fair market value on the date the parties submit the authorization request.

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(4) In the event that the transaction consists of a loan or a financing agreement, the consideration includes the total value of the loan, including the accrued interest, or of a similar financing arrangement, made available or provided by the investor or the investor who is a party to the transaction.

(4) In the event that the transaction consists of a loan or a financing agreement, the consideration includes the total value of the loan, including the accrued interest, or of a similar financing arrangement, made available to the investor or provided by the investor or to the investor who is a party to the transaction. This provision does not apply to loans/financing granted by authorized financial institutions, such as banks or non-bank financial institutions, in the ordinary course of professional lending activity in Romania, under which they do not acquire any right of management or control over the borrowing entities.

Ibid.

(5) In the event that the transaction consists of or includes the conversion of a previously acquired equity interest by the investor who is a party to the transaction, the consideration includes what was paid by the investor or on their behalf to initially acquire the equity, in addition to any other consideration paid or to be paid in connection with the conversion.

(5) In the event that the transaction consists of or includes the conversion of a previously acquired equity interest by the investor who is a party to the transaction, the consideration includes the amount paid by the investor or on their behalf to initially acquire the equity, in addition to any other consideration paid or to be paid in connection with the conversion.

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(6) In the event that the consideration includes securities traded on a stock exchange, the value is the closing price of the securities on the exchange where they are traded on the trading day immediately preceding the date of submission of the authorization request, or, if the securities were not traded on that day, the last published closing price.

(6) In the event that the consideration includes securities traded on a stock exchange, the value is the closing price of the securities on the exchange where they are traded on the trading day immediately preceding the date of submission of the authorization request, or, if the securities were not traded on that day, the last published closing price.

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(7) In the event that an investment is made in multiple stages, the value of the investment is determined by the cumulative total of the values corresponding to each stage.

(7) If an investment is made in multiple stages, the value of the investment is determined by adding together the values corresponding to each stage.

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(8) If the investment also involves assets or contributions subject to terms or conditions that, by their purpose, nature, or objective, are considered to be established for the purpose of carrying out the investment, the total value of the investment includes the value of these as well.

(8) If the investment also involves assets or contributions subject to terms or conditions that, by their purpose, nature, or objective, are considered to have been established for the purpose of carrying out the investment, the total value of the investment includes them. şi valoarea acestora.

Here, one could think of potential option rights. In this case, it would be useful to clarify beyond any doubt that the subsequent exercise of the option will no longer trigger a notification obligation.

(9) When an investment is part of a multi-jurisdictional transaction and the price allocated to the enterprise/assets in Romania is not separately identified, the value of the investment is determined based on valuations provided by the parties. Otherwise, the value of the investment will be considered to be the total value of the multi-jurisdictional transaction.

(9) When an investment is part of a multi-jurisdictional transaction and the price allocated to the enterprise/assets in Romania is not separately identified, for the purpose of determining the investment threshold referred to in art. 3(1)(b) of O.U.G. no. 46/2022, the valuations provided by the parties regarding the enterprise/assets registered or located in Romania are taken into account. If no price is allocated for the enterprise/assets in Romania or no valuations are provided by the parties regarding the enterprise/assets registered or located in Romania, the value of the investment will be considered to be the total value of the multi-jurisdictional transaction.

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Art. 5 – In order to demonstrate the intention to carry out an investment, the parties must present a document, preliminary contract, contract, or any other agreement that unequivocally demonstrates the intention to make the foreign investment.

Art. 5 – In order to demonstrate the intention to carry out an investment, the parties must present a document, preliminary contract, contract, or any other agreement that unequivocally demonstrates the intention to make the foreign investment.

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Art. 6 – The authorization request shall be submitted after the completion of negotiations, once the most important aspects of the transaction have been established, but before the investment is implemented. By way of example, without being exhaustive, the price, financing method, parties, and subject matter constitute important aspects of the transaction.

Art. 6 – The authorization request shall be submitted after the completion of negotiations, once the most important aspects of the transaction have been established, but before the investment is implemented. By way of example, without being exhaustive, the price, financing method, parties, and subject matter constitute important aspects of the transaction.

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Art. 7 - (1) The notion of “control” refers to the concept of control as defined in art. 9 para. (5) and (6) of the Competition Law no. 21/1996, republished, with subsequent amendments and completions, and includes transactions leading to the creation of joint ventures, as provided in the Companies Law no. 31/1990, republished, with subsequent amendments and completions.

Art. 7 - (1) The term “control” refers to the concept of control as defined in art. 9 para. (5) and (6) of the Competition Law no. 21/1996, republished, with subsequent amendments and completions, and includes transactions leading to the creation of joint ventures, as provided in the Companies Law no. 31/1990, republished, with subsequent amendments and completions.

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(2) For the concept of control, reference shall be made to Part B, Chapter II, Sections 1, 2, and 3 of the 2010 Competition Council Guidelines regarding the concepts of economic concentration, involved undertaking, full-functioning, and turnover.

(2) For the concept of control, reference shall be made to Part B, Chapter II, Sections 1, 2, and 3 of the 2010 Competition Council Guidelines regarding the concepts of economic concentration, involved undertaking, full-functioning, and turnover.

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Art. 8 – These instructions shall be implemented by order of the President of the Competition Council and shall be published in the Official Gazette of Romania, Part I.

Art. 8 – These instructions shall be implemented by order of the President of the Competition Council and shall be published in the Official Gazette of Romania, Part I.

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[1] The Guidelines issued pursuant to the provisions of Article 3(5) of Government Emergency Ordinance No. 46/2022 on the measures for implementing Regulation (EU) 2019/452 of the European Parliament and of the Council of 19 March 2019 establishing a framework for the screening of foreign direct investments into the Union, as well as for amending and supplementing Competition Law No. 21/1996, dated 22 July 2025, approved by Order No. 2112/2025 of the Competition Council, published in the Official Gazette, Part I, No. 707 of 30 July 2025.

[2] The letters in bold indicate the difference between the Guidelines and the Draft, i.e., newly added text.

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