(ii) for Mexico: the Federal Public Administration, including any decentralised bodies of the Federal Public Administration; and
(b) "regulatory measures" means measures of general application, developed by a regulatory authority and adopted by a Party with which compliance is mandatory, which are:
(i) for the European Union:
(A) regulations and directives, as provided for in Article 288 of the TFEU; and
(B) delegated and implementing acts, as provided for in Articles 290 and 291 TFEU, respectively; and
(ii) for Mexico:
(A) laws and legislative decrees presented by the executive branch of the Federal Government; and
(B) any other administrative acts of general application, including, but not limited to, regulations, decrees, agreements and Normas Oficiales Mexicanas ("NOMs", Mexican Official Standards).
ARTICLE 28.2
General Principles
1. The Parties recognise the importance of:
(a) using good regulatory practices in the process of planning, designing, issuing, implementing, evaluating and reviewing regulatory measures in order to achieve domestic policy objectives; and
(b) maintaining and enhancing the benefits of this Agreement through the use of good regulatory practices to facilitating trade in goods and services and increasing investment between the Parties.
2. Each Party shall have the right to determine its approach to good regulatory practices under this Agreement in a manner consistent with its own legal framework, practice and fundamental principles 86 underlying its regulatory system.
3. The provisions in this Chapter shall not be construed as requiring a Party to:
(a) deviate from domestic procedures for identifying its regulatory priorities and for preparing and adopting regulatory measures ensuring the levels of protection that it considers appropriate;
(b) take actions that would undermine or impede the timely adoption of regulatory measures to achieve its public policy objectives; or
(c) achieve any particular regulatory outcome.
ARTICLE 28.3
Scope
1. This Chapter applies to regulatory measures in respect to any matter covered by this Agreement.
2. This Chapter does not apply to regulatory authorities and regulatory measures, practices or approaches of the Member States.
ARTICLE 28.4
Internal Consultation and Coordination of Regulatory Development
1. The Parties recognise that the implementation of good regulatory practices can be facilitated through domestic mechanisms that improve internal consultation and coordination required for processes or mechanisms for the development of regulatory measures.
2. Each Party shall adopt or maintain internal coordination or review processes or mechanisms with respect to regulatory measures that its regulatory authority is developing.
3. Such processes or mechanisms should seek, among others, to:
(a) foster good regulatory practices, including those set out in this Chapter;
(b) strengthen internal consultations and coordination for the identification and avoidance of unnecessary duplication and inconsistency of the requirements in the Party's regulatory measures;
(c) promote that the potential impacts of the regulatory measures under preparation, including those on small and medium-sized enterprises, are taken into consideration in the subsequent decision making process;
(d) ensure compliance with international trade and investment obligations; and
(e) promote that relevant developments in international and other fora are taken into consideration.
4. The Parties recognise that the processes or mechanisms referred to in paragraph 2 may vary depending on their respective circumstances. In this regard, each Party may, in accordance with its domestic rules and procedures, improve its regulatory system through additional internal consultation and coordination mechanisms.
5. Each Party may establish or maintain a central coordinating body.
ARTICLE 28.5
Transparency of the Regulatory Processes and Mechanisms
Each Party shall make publicly available descriptions of the processes and mechanisms used by its regulatory authority to prepare, evaluate or review regulatory measures. Those descriptions shall refer to relevant guidelines, rules or procedures, including those regarding opportunities for the public to provide comments.
ARTICLE 28.6
Early Information on Planned Regulatory Measures
1. Each Party shall make publicly available, at least on an annual basis, a list of planned major 87 regulatory measures that its regulatory authority reasonably expect to adopt within the year.
2. With respect to each of the regulatory measures included in the list referred to in paragraph 1, each Party should also make publicly available:
(a) a brief description of its scope and objectives; and
(b) the estimated time for its adoption including, if possible, the period for public consultation.
ARTICLE 28.7
Public Consultations
1. When developing a major regulatory measure, each Party shall, in accordance with its rules and procedures:
(a) publish either a draft regulatory measure or consultation documents that provides sufficient details about the new regulatory measure under preparation in order to allow any person to assess whether and how its interests might be significantly affected;
(b) offer reasonable opportunities for any person, on a non-discriminatory basis, to provide comments; and
(c) consider the comments received.
2. Each Party should make use of electronic means of communication and seek to use a dedicated single access point for providing information related to public consultations, including on how to provide comments.
3. Each Party shall make publicly available any comments it receives, as well as a summary of the results of the consultations. This obligation does not apply to the extent necessary to protect confidential information or personal data, or to withhold inappropriate content.
ARTICLE 28.8
Regulatory Impact Assessment
1. Each Party shall promote that its regulatory authority, in accordance with the applicable rules and procedures, carries out regulatory impact assessments when developing major regulatory measures.
2. When carrying out an regulatory impact assessment in accordance with paragraph 1, the regulatory authority of each Party shall establish and maintain processes and mechanisms that promote the consideration of the following factors:
(a) the need for a regulatory measure, including the nature and significance of the problem the regulatory measure is intended to address;
(b) any feasible and appropriate regulatory and non-regulatory alternatives, including the option of not regulating, that would achieve the public policy objective of that Party;
(c) to the extent possible and relevant, the potential costs and benefits and social, economic and environmental impact of those alternatives, including on international trade and investment and on small and medium-sized enterprises; recognising that some costs and benefits are difficult to quantify and to express in monetary terms;
(d) how the options under consideration relate to relevant international standards, including the reason for any divergence, where appropriate; and
(e) how the public policy objectives are best achieved in terms of effectiveness and efficiency.
3. When carrying out an regulatory impact assessment in accordance with paragraph 1, the regulatory authority shall rely on the best reasonably obtainable evidence including scientific, technical, economic or other information.
4 With respect to any regulatory impact assessment that a regulatory authority has carried out for a regulatory measure, the Party concerned shall prepare a final report that sets out in detail the factors the regulatory authority considered in its assessment and the relevant findings. Such report shall be made publicly available no later than the date the regulatory measure is made publicly available.
ARTICLE 28.9
Retrospective Evaluation
1. The regulatory authority of each Party shall maintain processes or mechanisms to promote periodic retrospective evaluations or reviews of its regulatory measures at intervals it deems appropriate.
2. When conducting a periodic retrospective evaluation the regulatory authorities of a Party shall consider whether there are opportunities to more effectively achieve public policy objectives and to reduce unnecessary regulatory burdens, including on small and medium-sized enterprises. On the basis of those periodic retrospective evaluations, each Party should determine whether its regulatory measures should be modified, streamlined, expanded or repealed.
3. Each Party shall make publicly available its plans for and the results of such periodic retrospective evaluations.
ARTICLE 28.10
Regulatory Register
Each Party shall ensure, in accordance with its rules and procedures, that regulatory measures, which are in effect are available on a single, freely accessible website. That website should allow searches for regulatory measures by citation or by word and be periodically updated.
ARTICLE 28.11
Contact Point
1. The contact points for communication between the Parties on matters arising under this Chapter are:
(a) in the case of Mexico, the General Directorate for International Trade Disciplines of the Undersecretariat of Foreign Trade of the Ministry of Economy, (Dirección General de Disciplinas de Comercio Internacional de la Subsecretaría de Comercio Exterior de la Secretaría de Economía) or its successor; and
(b) in the case of the European Union, the Directorate-General for Trade, or its successor.
2. Each contact point is responsible for consulting and coordinating within its respective regulatory authority, as appropriate, on matters arising under this Chapter.
3. Each Party shall notify the other Party of the contact details of its contact point and promptly notify the other Party of any changes to those contact details.
ARTICLE 28.12
Cooperation and Exchange of Information
1. The Parties shall cooperate in order to facilitate the implementation of this Chapter. This may include the organisation of any relevant activities, including mutual assistance, to strengthen cooperation between their regulatory authorities.
2. No later than one year after the date of entry into force of this Agreement, the Parties shall exchange information on their existing rules and procedures on good regulatory practices and, if applicable, on any steps taken for the implementation of this Chapter.
ARTICLE 28.13
Dispute Settlement
A Party shall not have recourse to dispute settlement under Chapter 31 (Dispute Settlement) concerning the application or interpretation of the provisions of this Chapter.
Chapter 29. SMALL AND MEDIUM-SIZED ENTERPRISES
ARTICLE 29.1
Objective
The Parties recognise the importance of enhancing cooperation on matters relevant for small and medium-sized enterprises (hereinafter referred to as "SMEs") by the means provided for in this Chapter as well as by other provisions of this Agreement that may otherwise be of particular benefit to SMEs.
ARTICLE 29.2
Information Sharing
1. Each Party shall establish or maintain a publicly accessible website containing information regarding this Agreement, including:
(a) the text of this Agreement, including all annexes;
(b) a summary of this Agreement; and
(c) information designed for use by SMEs that shall contain:
(i) a description of the provisions of this Agreement that the Party considers to be relevant for SMEs of both Parties; and
(ii) any additional information that the Party considers useful for SMEs interested in benefitting from the opportunities provided under this Agreement.
2. Each Party shall include in the website referred to in paragraph 1 links to:
(a) the equivalent website of the other Party; and
(b) the websites of its government authorities and other appropriate entities that the Party considers would provide useful information to SMEs interested in trading or doing business in that Party.
3. The websites referred to in subparagraph 2(b) shall include information related to the following:
(a) customs laws and regulations, and procedures for importation, exportation and transit as well as forms and documents required therefor;
(b) laws and regulations, and procedures concerning intellectual property rights;
(c) technical regulations and, in cases where third party conformity assessment is mandatory as provided for in Chapter 9 (Technical Barriers to Trade), mandatory conformity assessment procedures and links to lists of conformity assessment bodies;
(d) sanitary and phytosanitary measures relating to importation and exportation;
(e) rules on public procurement, a database containing public procurement notices and the relevant provisions of Chapter 21 (Public Procurement);
(f) business registration procedures; and
(g) other information which the Party considers to be useful to SMEs.
4. Each Party shall include in the website referred to in paragraph 1 a link to a database that is electronically searchable by tariff nomenclature code. That database shall:
(a) include the following information with respect to access of goods to its market:
(i) rates of customs duties and tariff rate quotas, if applicable, concerning most-favoured nation and non most-favoured nation countries as well as preferential rates of customs duties and tariff rate quotas;
(ii) excise duties;
(iii) value added tax;
(iv) customs charges or other fees, including product-specific fees;
(v) rules of origin as provided for in Chapter 3 (Rules of Origin and Origin Procedures); and
(vi) criteria used to determine the customs value of goods; and
(b) endeavour to include the following information with respect to access of goods to its market:
(i) other tariff measures;
(ii) duty drawback, deferral or other types of relief that reduce, refund or waive customs duties;
(iii) if applicable, country of origin marking requirements, including placement and method of marking;
(iv) information required for import procedures; and
(v) information related to non-tariff measures.
5. Each Party shall regularly update the information and links provided pursuant to paragraphs 1 to 4 to ensure they are accurate.
6. Each Party shall ensure that the information provided in accordance with this Article is presented in a manner adequate for the use of SMEs. Each Party shall endeavour to make the information available in English.
7. A Party shall not apply any fee for access to the information provided pursuant to paragraphs 1 to 4 to any person of a Party.
ARTICLE 29.3
SME Contact Points
1. Each Party shall designate a contact point ("SME Contact Point") in charge of the functions set out in this Article and shall notify the other Party of its contact details. The Parties shall promptly notify each other of any changes to those contact details.
2. The SME Contact Points shall:
(a) ensure that the needs of SMEs are taken into account in the implementation of this Agreement and consider ways to increase trade and investment opportunities for SMEs by strengthening cooperation between the Parties on SME matters;
(b) identify ways and exchange information for SMEs of the Parties to take advantage of new opportunities created under this Agreement;
(c) ensure that the information included in the websites referred to in Article 29.2 is up-to-date and relevant for SMEs, and consider including in those websites any additional information that an SME Contact Point may recommend;
(d) address any other matter of interest to SMEs in connection with the implementation of this Agreement with regards to SMEs, including by:
(i) exchanging information;
(ii) participating, if appropriate, in the work of the sub-committees and working groups established under this Agreement, and presenting to those sub-committees and working groups, in their respective specific areas of activity, matters and recommendations of particular interest to SMEs, while avoiding duplication of work programmes; and
(iii) identifying and proposing possible mutually acceptable solutions for improving the ability of SMEs to engage in trade and investment between the Parties;
(e) report periodically on their activities for the consideration of the Trade Committee; and
(f) consider any other matter arising under this Agreement pertaining to SMEs as the Parties may agree.
3. SME Contact Points shall meet as necessary and shall carry out their work through the appropriate communication channels agreed by the SME Contact Points which may include electronic mail, videoconferencing or other electronic communication means.
4. SME Contact Points may seek to cooperate with experts and external organisations, as appropriate, in carrying out their activities.
ARTICLE 29.4
Non-Application of Dispute Settlement
A Party shall not have recourse to dispute settlement under Chapter 31 (Dispute Settlement) concerning the interpretation or application of the provisions of this Chapter.
Chapter 30. RAW MATERIALS
ARTICLE 30.1
Definitions
For the purposes of this Chapter:
(a) "authorisation" means the permission, license, concession or similar administrative or contractual instrument by which the competent authority of a Party entitles an entity to exercise a certain economic activity in its territory;
(b) "entity" refers to any natural person or enterprise or group thereof; and
(c) "raw materials" means substances used in the manufacture of industrial products, excluding processed fishery products and agricultural products, which consist of salt, sulphur, earths and stone, plastering materials, lime and cement (HS 25); ores, slag and ash (HS 26); goods included in HS 27; inorganic chemicals (HS 28); organic chemicals (HS 29); fertilisers (HS 31); natural rubber (HS 40); raw hides, skins and leather (HS 41); and basic and precious metals and processed minerals (ex HS 71, 72; 74-76; 78-81), excluding uranium and thorium (HS 26.12) and radioactive elements and isotopes (HS 28.44, 28.45).
ARTICLE 30.2