Chemical Regulation in the Middle East

Dedication

To Cynde

Introduction

Historically, chemical regulation in the Middle East has been a national patchwork of regulations, with the substances and applications potentially experiencing varying types of requirements. Indeed, the level of sophistication of chemical control regulations varies greatly as a result of different levels of economic and industrial development.¹ At one end of the spectrum lies Israel, which has a fairly comprehensive system of such regulations in place, often mirroring closely those of the United States and/or the European Union. At the other end can be found countries such as Pakistan, where such laws are perhaps more the exception than the rule. Indeed, the level of sophistication varies greatly as the result of different levels of economic and industrial development.²

While many of the countries to be discussed have exhibited an intent, if not a formal action plan, to develop such schemes, they are normally less advanced in this regard than entities such as the United States, the European Union, and various Asia‐Pacific‐region countries such as Japan, Australia, and South Korea. Generally, there are no national chemical inventory programs in the Gulf States region; instead, such countries tend to focus more on a system of permits and licenses to manage chemicals. There are, however, often a wide variety of Ministry, legislative, and other decrees which relate to pesticides, Occupational Safety and Health, Safety Data Sheets, and product labels, again to widely varying degrees.

Before moving forward, readers should be aware of two key issues with respect to how regulations are referenced in many of the countries of the Middle East. First, with respect to the date format employed, Gulf countries typically use the Islamic calendar for religious purposes, but the Gregorian for secular purposes.³ Indeed, [t]he Islamic calendar has 12 months, each with 29 or 30 days. The Islamic calendar year is 11 days shorter than the Gregorian calendar year.⁴ It is not uncommon to see both the Islamic calendar and the Gregorian calendar date presented when examining a particular regulation from the region. For example, the Egyptian Prime Minister's Decree No. 338 of the Year 1995 is internally cited as having been Issued in the Cabinet on 18 Ramadan Hejira Year 1415 (Corresponding to February 18, 1995).⁵ Second, regulations often present the date of promulgation using only the year, and do so in two different ways. The more common format is to display the regulation name, followed by the year of enactment in parentheses, such as Legislative Decree No. 11 (1989). An alternative way of displaying a regulation title in the region is to note the date of enactment after the title and following a / symbol, such as Royal Decree 84/2011. These formats tend to vary from country to country, but are generally consistent within a given country.

Acknowledgments

This work would not have been possible without the extremely generous support of Lynn L. Bergeson, President, The Acta Group, and Lisa M. Campbell, Partner, Bergeson & Campbell, P.C.

I would also like to thank Elsie Merlin, Project Editor, Physical Sciences and Engineering, and Emma Strickland, Assistant Editor, as well as all of the technical reviewers at John Wiley and Sons, Ltd. for their dedication, patience, and guidance.

Thank you to my parents, whose love and guidance are with me in whatever I pursue.

Finally, I wish to thank my best friend, my ana mandara – beautiful refuge – my wife Cynde for her unwavering support, love, and encouragement.

1

The Cooperation Council for the Arab States of the Gulf

National Overview

The Cooperation Council for the Arab States of the Gulf (alternatively the GCC or the Council) is a cooperative framework, launched on May 25, 1981 (21st Rajab 1401 AH in the Islamic calendar), to effect coordination, integration and inter‐connection among the Member States.⁶ The GCC, headquartered in Riyadh, Saudi Arabia, is comprised of six Member States: the United Arab Emirates (which itself is composed of Sharjah, Ajman, Dubai, Abu Dhabi, Fujairah, Ras al‐Khaimah, and Umm al‐Quwain), Kuwait, Saudi Arabia, Bahrain, Qatar, and Oman. Each of these entities is an autocratic monarchy or sheikhdom and, consequently, has little to no citizen participation in their political processes. All GCC members are also members of the Arab League and Qatar, Saudi Arabia, Kuwait and the United Arab Emirates are prominent members of OPEC.⁷

Governmental Structure

The GCC is vested with the authority to issue mandatory laws and technical regulations, as well as voluntary standards. However, it should be noted that sovereignty resides with each Member State, which may or may not choose to adopt these types of regulatory devices.⁸ A loose parallel may be seen with regard to the European Union (EU), where regulations become immediately enforceable as law in all Member States simultaneously, while directives must be passed into national law by each individual Member State. Further, GCC Member States are also entitled to introduce more stringent requirements at the national level, on condition that they adhere to the GCC framework.⁹ The GCC is governed by a series of agencies, as follows:

The Supreme Council, to which shall be attached the Commission for Settlement of Disputes;

The Ministerial Council; and

The Secretariat General.

The GCC has established a nascent defense force (1984), developed an intelligence sharing agreement (2004), and created a common market similar to that of the EU in 2008. However, as with the EU, a single currency adopted by all Member States was not established.¹⁰ Indeed,

The decision [to form such an alliance] was not a product of the moment but an institutional embodiment of a historical, social and cultural reality. Deep religious and cultural ties link the six states, and strong kin relations prevail among their citizens… Therefore, while, on [the] one hand, the GCC is a continuation, evolution and institutionalization of old prevailing realities, it is, on the other [hand], a practical answer to the challenges of security and economic development in the area. It is also a fulfilment of the aspirations of its citizens towards some sort of Arab regional unity.¹¹

According to the Charter of the Gulf Cooperation Council (Charter), enacted on May 25, 1981, the goals of the GCC are:¹²

To effect coordination, integration, and inter‐connection between Member States in all fields in order to achieve unity between them.

To deepen and strengthen relations, links, and areas of cooperation now prevailing between their peoples in various fields.

To formulate similar regulations in various fields, including the following:

A. Economic and financial affairs;

B. Commerce, customs, and communications;

C. Education and culture;

D. Social and health affairs;

E. Information and tourism; and

F. Legislative and administrative affairs.

The 1981 Unified Economic Agreement Between the Countries of the Gulf Cooperation Council (Agreement) requires Member Countries to coordinate activities in the areas of trade, commercial [development], customs, financial, import, export, transportation, communication policies, professional and technical training, as well as in projects facilitating overall economic development.¹³

Key Chemical Regulatory Agencies

The Standardization Organization of the Cooperation Council for the Arab States of the Gulf, also known as the GCC Standardization Organization (GSO, or Organization), is also headquartered in Riyadh. Generally speaking, the function of the Organization is to develop GCC‐wide standards for a variety of aspects, including but not limited to: water, fire protection, Halal foods, cigars and cigarettes, and food safety. Where no GSO standard already exists, the Organization may elect to review existing global standards and to adopt them, or permutations thereof, as it sees fit.

One example of such a standard implemented by the Organization is the GSO Technical Regulation on Toys: Second Edition – BD‐131704‐01 from November 27, 2007. This technical regulation was adopted by the GSO Board of Directors at its 17th meeting (May 31, 2013) and entered into force on January 1, 2014.¹⁴ Specific to chemical regulation, the GSO Technical Regulation on Toys

has required the amendment of the essential requirements, especially with regard to the prohibition of the use of certain chemicals that cause cancer or genetic defect or allergies or concerning the use of fragrances, as well as the maximum limits permitted for certain substances especially in toys intended for use by children under thirty‐six months or toys that children can put in their mouths.¹⁵

Key Chemical Substance Regulations

In 1997, the GCC published the General Regulations of Environment in the GCC States (Regulation), recognizing that The great developmental growth, in the last few years in GCC States, has created some negative results, which are considered a clear threat to the environment in the area and calls for positive attention and consideration.¹⁶ This regulation, while specific in title to the environment, has implications with respect to the management of chemical substances in the GCC.

While some of the language of Article 1 of the Regulation may be viewed as fairly grandiose (e.g. Every person has a basic right to live a convenient life in an environment compatible with human dignity), Section 4 lays out the specific responsibility for the management of the environment, stating

The responsibility for management of the environment, its natural and wildlife resources, particularly the ability of the natural resources to satisfy the development needs of the present and future generations, lies on the shoulders of the official authorities, public and private establishments as well as responsible and ordinary persons.¹⁷

Specifically, Section 7 directs

[e]nvironmental considerations should be taken into consideration and given foremost priorities. These priorities should be merged with all stages and levels of planning so as to make environmental planning an integral part of the comprehensive development planning in all industrial, agricultural, constructional and other field [sic]…¹⁸

As a result, consideration of the natural environment as early as possible in the planning stages of a wide variety of areas is paramount. Section 10 focuses new facilities and projects on the use of Best Available Technology (BAT) with respect to controlling pollution and preventing environmental degradation, as well as directing existing projects to use the technologies that guarantee compliance with environmental feasibility standards… or the technologies that prevent the occurrence of any substantial negative effect on the environment.¹⁹ As an aside, Article 6 of the Regulation speaks more specifically to the use of BAT.

Article 3 of the Regulation lays out the Duties of the Public Bodies with respect to environmental management, specifically:²⁰

Working to prevent negative environmental effects which may result from their own projects or projects under their supervision or licensed by them;

Taking all suitable measures to guarantee application of the rules stipulated in this regulation on their own projects under their supervision or licensed by them, including compliance with the environmental protection regulations and standards in force, in addition to issuing the necessary rules, regulations, and additional guidelines in this regard in consultation with the concerned authority;

Monitoring the application of the environmental regulations and standards and compliance with them on their own projects or projects supervised or licensed by them and preparing periodic reports about their effectiveness and the extent of compliance to them; and

Any public body responsible for issuing standards, specifications, or rules related to activities affecting the environment should give the concerned authority ample opportunity to give its opinion before granting such licenses or permits or issuing such regulations, standards, or specifications.

Article 4 defines the Duties of Persons with respect to the same:²¹

Any person responsible for the design or implementation of any project should make sure that the design and operation of such a project complies with the regulations and standards of environment protection;

Any person intending to do any work, or neglecting to do any work, that may lead to the occurrence of negative effects on the environment should seek, through studying the environment assessment or any other suitable means, to identify those probable effects and take all suitable measures to prevent such negative effects or reduce their probability to the lowest possible level;

In case of the occurrence of any of the probable negative effects, the concerned person should take the necessary steps to stop or alleviate such effects; and

The person responsible for any work that causes damage to the environment, or a negative effect on the environment caused by his neglect, shall not be absolved from the responsibility for the damage caused to the environment as a result of his actions or negligence even after complying with the provisions of Paragraph (2) of this Article.

Related to the foregoing, Article 7 recommends that those individuals who have a supervisory position and/or role in projects which may have intense negative effects on the environment should designate an employee whose role will be to ensure compliance with the Regulation, as well as any other regulations issued by virtue of it, thus further cementing the role of environmental protection efforts in the types of projects and sectors addressed previously.²² Subsequent Articles discuss the management of land, and specifically of coastal areas (Article 9, Land Uses and Coastal Zones), management of species, both animal and plant, as well as their attendant habitats (Article 10, Conservation of the Living Species), and the maintenance, management, and further development of renewable and non‐renewable resources (Article 11, Rationalization of the Use of Natural Resources) and environmental education at both primary and secondary school levels, and also in the technical training environment (Article 12, Environmental Education and Environ‐mental [sic] Awareness).²³

The final four Articles of the Regulation relate in various forms to the additional requirements the authority may impose on the person conducting the project (Articles 17 and 19), the penalties which may be levied by those entities failing to comply with the requirements set out (Article 18), and the right of the authority to inspect projects at its discretion (Article 20).

Article 17 (Application of Environmental Protection Standards) grants the responsible authority the ability to require a specific set of data if in the opinion of the concerned authority, [it] may produce pollutants or lead to deterioration of the environment.²⁴ Such information may include the nature of the activities and the materials used, the wastes from the activities, and/or the methods or equipment used to reduce or stop the resultant pollution or environmental degradation.²⁵

Article 18 (Infringement of the Environmental Laws) directs the concerned authority, once it becomes certain – interestingly, not simply on the basis of suspicion – to ask the responsible person to submit a report detailing the steps that will be undertaken in order to prevent the infringement from reoccurring.²⁶ The responsible authority must approve the steps, and may ask the person to both remove the solid, liquid, or gaseous wastes or any other negative effects caused, and to restore the situation to its original condition before the occurrence of the infringement whenever possible.²⁷ In situations where failure to comply with attendant obligations has been observed, the responsible authority may additionally require the suspension of work on the project which has caused the non‐compliance event(s), until appropriate measures are taken.²⁸

Article 19, similar in concept and scope to Article 17, grants the authority the ability to take the measures it deems necessary to avoid, prevent, or reduce damage to the lowest possible level before it occurs.²⁹ This ability may manifest itself by directing a work stoppage (temporary or permanent), imposing restrictions on the work activities which are to be performed, imposing technical, operational, or other standards, and/or any other means which the concerned authority deems fit.³⁰

Finally, Article 20 (Inspection) entitles the authority concerned to enter facilities as it sees fit, and to request and remove samples from refuse and the materials used or stored in the project or produced by it, to verify compliance with applicable regulations and standards.³¹

While the Regulation sets forth a baseline effort, the ensuing 2002 Common System for the Management of Hazardous Chemicals in the Gulf Cooperation Council for the Arab States of the Gulf (Common System) laid out the minimum legislative requirements for each Member State for managing hazardous chemicals; again, for those entities which chose to incorporate them into national law.³² The Common System contained no provisions for a GCC‐wide chemicals notification or similar management scheme.³³ The GCC does, however, ban the sale and consumption of substances defined as ozone‐depleting under the Montreal Protocol.³⁴ Further, there is no overarching regulation or law at the GCC level to manage Volatile Organic Compounds (VOCs). These compounds are regulated mainly through standards and technical rules.³⁵

Article I of the Common System delineates those substances which are considered to be hazardous chemicals as:

Chemicals in gaseous, liquid or solid form(s) as referred to in the category lists (attached hereto) and characterized to be effective, toxic, explosive, corrosive or other characteristics that can result in a hazard to human health and environment, whether on their own or when in contact with other materials.³⁶

Environmental hazards are defined to be Direct and accumulated hazards that occur in water, air and soil, can potentially pose a risk to man, flora and fauna, cause damage to living resources and ecosystems, and minimize other habitual uses of environmental sources, individually or combined.³⁷ Annex I of the Common System further lists the specific classifications of hazardous chemicals. Generally speaking, these classifications mirror the United Nations Recommendations on the Transport of Dangerous Goods (UN Recommendations) classifications of the same, which are contained in the UN Model Regulations prepared by the Committee of Experts on the Transport of Dangerous Goods of the United Nations Economic and Social Council (ECOSOC):³⁸

Category 1: Explosive materials

Category 2: Compressed or liquid gases

Category 3: Flammable liquids

Category 4: Flammable solid materials

Category 5: Oxidizing agents

Category 6: Toxic materials

Category 8: Corrosive materials

Category 9: Other hazardous materials

Readers should note, however, that Annex I does not include the UN Recommendations Category 7: Radioactive material. In addition, as stated above, Annex I only largely follows the UN Recommendations, especially with respect to classification. One example of this may be seen when comparing the Common System definition of a flammable solid with the UN Recommendations definition of the same, respectively:³⁹

Flammable solid materials:

1. Are readily combustible and can cause fire through friction.

2. Are in powdery, granular or paste form, and, if easy to burn on contact with a source of combustion, can be hazardous. Hazard can be formed by fire and combustion toxic products as well.

3. Fires caused by metal powders are difficult to extinguish, hence the particular hazard they form. Ordinary extinguishing materials such as carbon dioxide and water can increase risk.

versus

Division 4.1 Flammable solids

Solids which, under conditions encountered in transport, are readily combustible or may cause or contribute to fire through friction; self‐reactive substances and polymerizing substances which are liable to undergo a strongly exothermic reaction; solid desensitized explosives which may explode if not diluted sufficiently.⁴⁰

Article II of the Common System, Scope of Application, sets out that the regulation shall apply to: ⁴¹

[a]ll practices which comprise hazardous chemicals management, including:

a. [p]roduction and various (industrial, agricultural, veterinary) uses of hazardous materials for educational, research or training activities, or in any other activity associated with a certain use, which involves dealing with chemicals [,]

b. [a]ny other practices determined by the competent regulatory authority in the state, [and]

c. [e]xcept for drugs and narcotics for medical purposes, radioactive materials, explosives and weapons.

Thus, while the Common System appears to exempt the normal applications and uses for chemical substances, similar to the chemical legislation in various other countries outside the GCC – medical purposes, radioactive materials, explosives, and weapons – it does, interestingly, retain control over agricultural and veterinary applications. Many of these other countries exclude such compounds from their national law of chemical substances, as they are often managed by other regulations.

Article III sets out what the Common System calls the Basic Obligation[s] of those to whom the System is applicable:⁴²

Unless authorized and monitored by the competent regulatory authority, no practices or procedures involving dealing with hazardous chemicals or relevant equipment shall be applied, introduced, conducted, modified, suspended, or terminated;

Unless authorized and monitored by the competent regulatory authority, no hazardous chemical shall be manufactured, produced, acquired, possessed, imported, exported, purchased, sold, delivered, received, lended, borrowed, modified, circulated, used, transported, stored, ceased from operation, or discharged; [and]

Unless authorized by the competent regulatory authority, no site for any practices or work involving a hazardous chemical or equipment involving a hazardous chemical shall be allocated; nor shall any relevant buildings, facilities, or places be set up or modified for the same.

As discussed earlier, there is presently no chemical substance registration or other notification requirement in GCC regulations. Interestingly, though, Section 5 of Article IV (Responsibilities of the Competent Regulatory Authority) requires the competent authority to:

Set up national databases for hazardous chemicals as regards their chemical and physical properties and hazards, secure constant and accurate statistics [undefined] of hazardous chemicals, and periodically publish the same in journals as considered vitally important for data reporting and operational studies.⁴³

It seems unusual to set up national databases only to seemingly separately record the chemical and physical properties and also the hazards of such substances, data which is freely available on the Safety Data Sheet (SDS) of such materials from a variety of sources. The constant and accurate statistics are, as noted, not defined specifically in the Common System, so how the competent regulatory authority actually complies with Article IV is unclear.

Article V (Licensing) does appear to lay more formal groundwork regarding the use of chemical substances, but again stops short of delineating a specific registration scheme. Section 1 requires that Anyone… intending to implement any of the practices and/or works associated with hazardous chemicals, set forth in Article III, shall apply to the competent regulatory authority for a work and/or practice license.⁴⁴ Such a license shall be issued by the competent regulatory authority in the country for a specific period of time and practices.⁴⁵ Article V goes on to proscribe a prohibition against assigning the license to others (Section 4), the attendant data requirements, such as to retain a record of the trading movement… numbered and stamped by the competent regulatory authority and retained for a five‐year period… (Section 6), and a requirement to develop contingency plans for accidents, which are to be submitted to the competent authority in the country at issue (Section 9).⁴⁶ Such licenses are discussed later, in the specific country's section.

Article VI of the Common System lays out the issues relating to the importation of products, declaring in Section 1 that no import of hazardous substances may take place until approval of [read: by] competent regulatory authority and/or bodies concerned is obtained.⁴⁷ The approval, in the form of a license, may be granted provided the applicant provides the Authority with a Material Safety Data Sheet (MSDS) for the substance, as well as the following, at least 30 days prior to the start of the import process (Section 2):⁴⁸

The chemical's scientific and trade names and its chemical composition;

The chemical's UN number and Chemical Abstracts Service (CAS) numerical registry number;

The chemical's hazard degree and health and environmental effects;

The weight of hazardous chemical intended for importation;

Transportation date and time expected;

Importation purpose;

Optimal methods for chemical's storage and disposal;

Actions to be taken in case of hazardous material leakage;

The