{"id":12783,"date":"2009-02-09T00:00:00","date_gmt":"2009-02-09T05:00:00","guid":{"rendered":"http:\/\/www.farmchemicalsinternational.com\/2009\/02\/09\/european-commissions-new-chemical-strategy-reach\/"},"modified":"2019-09-16T13:47:32","modified_gmt":"2019-09-16T17:47:32","slug":"european-commissions-new-chemical-strategy-reach","status":"publish","type":"post","link":"https:\/\/www.agribusinessglobal.com\/es\/industry-news\/european-commissions-new-chemical-strategy-reach\/","title":{"rendered":"Nueva estrategia qu\u00edmica de la Comisi\u00f3n Europea (REACH)"},"content":{"rendered":"<p><a target=\"_blank\" href=\"http:\/\/www.reach-compliance.eu\" rel=\"noopener noreferrer\">REACH (Registration, Evaluation, and Authorization of Chemicals)<\/a> came into force June 1, 2007. The new regulation aims to improve the protection of human health and the environment while maintaining competitiveness and enhancing the innovative capability of the EU chemicals industry. REACH will furthermore give greater responsibility to industry to manage the risks from chemicals and to provide safety information that will be passed down the supply chain.<\/p>\n<p class=\"subhead\">What It Means<\/p>\n<p>Under REACH, all manufacturers and importers must register substances that they produce or import in quantities over one tonne per year. This includes individual substances, substances in mixtures or preparations, and in certain cases, in articles. It&#8217;s important to note the registrants must be based in the EU and should have intimate knowledge of the substance, preparation, or mixture and article in question.<\/p>\n<p>Downstream users must also inform their suppliers of the use of a substance, so appropriate safety assessments can be carried out, or they will need to carry out their own assessments for submission.<\/p>\n<p>The REACH procedure involves several steps, the first of which is pre-registration of &#8220;phase-in&#8221; substances. These are substances which are listed in EINECS and were manufactured in the past 15 years, but not placed on the market or are &#8220;no longer polymers.&#8221; This initial phase will last from June 2008 until November 2008. The pre-registration phase is next followed by the registration process. The deadlines for registration are as follows:<\/p>\n<ul>\n<li><strong>November 2010: Substances in quantities of 1,000 tonnes and above per year as well as carcinogens, mutagens, and substances toxic to reproduction above 1 tonne per year, and substances classified as very toxic to aquatic organisms above 100 tonnes.<\/strong><\/li>\n<li><strong>June 2013: Substances in quantities of 100 tonnes and above per year, as well as substances toxic for the aquatic environment.<\/strong><\/li>\n<li><strong>June 2018: Substances in quantities of 1 tonne or more.<\/strong><\/li>\n<li><strong>All new substances must be registered before they can be placed on the market.<\/strong><\/li>\n<\/ul>\n<p>The whole procedure will be overseen by the <a target=\"_blank\" href=\"http:\/\/echa.europa.eu\/\" rel=\"noopener noreferrer\">European Chemicals Agency<\/a>, based in Helsinki, which will become fully operational in June 2008. The requirements are detailed in the REACH regulation published in the Official Journal on December 30, 2006 [Regulation (EC) No. 1907\/2006 of the European Parliament and of the Council].<\/p>\n<p class=\"subhead\">The Dossier<\/p>\n<p>The technical dossier for registration must include results of various physicochemical, toxicological, ecotoxicological, and environmental tests. The extent and nature of these tests depend on the annual tonnage and becomes more demanding with increases in the tonnage levels. Based on the results, a chemical safety assessment must be prepared for all substances marketed in quantities of 10 tonnes or more per year per registrant. This assessment, which is included in a Chemical Safety Report, should consider all stages of the life-cycle resulting from the manufacture and all uses, including those indicated by downstream users. It should be based on a comparison of the potential adverse effects of the substance with the known or reasonable foreseeable exposure of man and\/or the environment. For certain substances, including those classified as dangerous or persistent, bioaccumulative, and toxic, a Safety Data Sheet is also required, which can be passed to other users.<\/p>\n<p>The next step in the process is evaluation which provides a follow-up to registration by allowing for checks on whether registrations are in compliance with the requirements of the REACH procedure. This follow-up, carried out by the competent authorities in the EU member states, will focus on a dossier of one registrant or consortium. In addition, the evaluation will assess any proposals for new tests, particularly those involving vertebrate animals.<\/p>\n<p>Evaluation may lead to the conclusion that action should be taken under the restriction or authorization procedures. Those substances which may come under the authorization procedure include those classified as category 1 or 2 carcinogens or category 1 or 2 mutagens, persistent, bioaccumulative, and toxic substances, and very persistent and very bioaccumulative substances. The authorization system is intended to ensure that such substances will be progressively replaced. Authorization may be granted if the risk to human health or the environment from the use of the substance can be adequately controlled, taking into account all discharges, emissions, and losses. In certain exceptional cases where adequate control is not possible, authorization may be granted based on a socio-economic analysis, and if no suitable alternatives are available. However, authorizations are time-limited and all applicants for authorization should provide an analysis of alternatives and any research and development program aimed at finding suitable alternatives.<\/p>\n<table class=\"croplifetable\" cellspacing=\"0\" cellpadding=\"5\" width=\"50%\" align=\"right\" bgcolor=\"#ffffff\" border=\"1\">\n<tbody>\n<tr>\n<th align=\"center\" colspan=\"3\">\n<p class=\"subhead\">Comparison Between The Present<br \/>\n            System And REACH<\/p>\n<\/th>\n<\/tr>\n<tr bgcolor=\"#ffcc66\">\n<td><strong>Present System<\/strong><\/td>\n<td><strong>REACH<\/strong><\/td>\n<\/tr>\n<tr bgcolor=\"#ffcc66\">\n<td valign=\"top\" bgcolor=\"#ffffff\">There are gaps in our knowledge about many of the chemicals on the European market.<\/td>\n<td valign=\"top\" bgcolor=\"#ffffff\">REACH will close the knowledge gaps by providing information on hazards and risks of chemicals produced or imported in volumes higher than 1 tonne\/year per manufacturer\/importer.<\/td>\n<\/tr>\n<tr>\n<td bgcolor=\"#ffcc66\">The &#8220;burden of proof&#8221; is on the authorities: They need to prove that the risk from the use of a chemical substance is unsafe before they may impose restrictions.<\/td>\n<td bgcolor=\"#ffcc66\">The &#8220;burden of proof&#8221; will be on industry. It needs to demonstrate that the risk from the use of a chemical can be adequately controlled, and recommend appropriate measures. All actors in the supply chain will be obliged to ensure the safety of the chemical substances they handle.&#160;<\/td>\n<\/tr>\n<tr bgcolor=\"#ffcc66\">\n<td bgcolor=\"#ffffff\">Notification requirements for &#8220;new substances&#8221; start at a production level of 10 kg. Already at this level, one animal test is needed. At 1 tonne, a series of tests including other animal tests have to be undertaken.<\/td>\n<td valign=\"top\" bgcolor=\"#ffffff\">Registration will be required for both old and new substances when the production or import reaches 1 tonne. As far as possible, animal testing will be minimized.<\/td>\n<\/tr>\n<tr>\n<td bgcolor=\"#ffcc66\">It is relatively costly to introduce a new substance on the market. This encourages the continued use of &#8220;existing&#8221;, untested chemicals and inhibits innovation.<\/td>\n<td bgcolor=\"#ffcc66\">Innovation of safer substances will be encouraged under REACH through: more exemptions for research and development; lower registration costs for new substances; and the need to consider substitute substances when applying for authorizations.<\/td>\n<\/tr>\n<tr>\n<td>Public authorities are obliged to perform comprehensive risk assessments that are slow and cumbersome.&#160;<\/td>\n<td>Industry will be responsible for assessing the safety of identified uses, prior to production and marketing. Authorities will be able to focus on issues of serious concern.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p class=\"subhead\">REACH In Crop Protection<\/p>\n<p>For the crop protection industry, it might be thought that given the stringent safety requirements demanded under Directive 91\/414 for plant protection products, including both active substances and co-formulants, that these would be exempt under the REACH legislation. Indeed, one important aspect of the new legislation was to ensure that there was no overlap with substances already adequately controlled by existing legislation. However, despite the need to avoid overlaps, the wording of the relevant part of the regulation (Article 15) is such that although pesticides on Annex I are exempt from registration, co-formulants will still fall under the remit of REACH and thus need to be registered.<\/p>\n<p>The crop protection industry will also be affected by the general impact from REACH in that there is likely to be an increased cost of chemicals, and some chemical substances may not be supported and will be removed from the market. Hence, the supply and cost of starting materials, which will need to be registered under REACH, for the production of pesticides may be affected, and there may be a need to reformulate if certain substances are withdrawn.<\/p>\n<p>Additionally, as isolated intermediates fall within REACH, manufacturers will need to go through the registration process even if they do not leave the factory. As REACH covers all chemicals, there may also be an indirect impact if chemicals used in producing the finished product, for example, printing inks or glues, are affected.<\/p>\n<p>All in all it is difficult to estimate the exact impact of REACH on the crop protection industry, but there will be an impact related to direct effects such as the additional costs of chemical substances, the withdrawal of certain substances, and possible reformulation costs, registration costs of starting materials, intermediates, and co-formulants, and possible indirect effects on other aspects of producing finished products.<\/p>\n<p class=\"subhead\">What Does &#8220;Review&#8221; Mean?<\/p>\n<p>REACH foresees that over the next 12 years after entry into force, the Commission will carry out a number of reviews of parts of the regulation to take into account any new experience gathered during a set time period and, where appropriate, present a legislative or quasi-legislative proposal to amend the law to ensure a high level of protection for human health and the environment.<\/p>\n<p>The term &#8220;review&#8221; in this legislative context should not be confused with the &#8220;reviews&#8221; the Commission will do in order to amend or withdraw time-limited authorizations granted to industry for a particular use of a substance of very high concern. The following information relates only to the reviews in the legislative context.<\/p>\n<p>Within <strong>12 months <\/strong>of entry into force of REACH, the Commission will review Annex I (rules for chemical safety reports), Annex IV (substances exempted from registration where sufficient information is known and the risk is minimal), and Annex V (substances exempted from registration under the current legislation).<\/p>\n<p>Within <strong>18 months<\/strong>, the Commission will review Annex XIII (criteria for identification of persistent, bio-accumulative, and toxic, or very persistent and very bio-accumulative substances (PBT&#8217;s and vPvBs)).<\/p>\n<p>After <strong>5 years<\/strong>, the Commission will review the scope of this Regulation to avoid overlaps with other relevant Community provisions and the rules concerning the European Chemicals Agency.<\/p>\n<p>After <strong>6 years<\/strong>, the Commission will review whether or not substances that have endocrine disrupting properties should still be authorized if a suitable, safer alternative exists.<\/p>\n<p>After <strong>7 years<\/strong>, the Commission will review whether or not to extend the obligation to submit a Chemical Safety Report (CSR) to CMR substances below 10 tonnes and after 12 years a similar review will consider all substances below 10 tonnes.<\/p>\n<p>Furthermore, the Commission will carry out a review on whether or not to extend the duty to inform consumers about substances in articles to other substances which are not of very high concern but which could still be dangerous or unpleasant (e.g. allergens). The requirement for a reproductive toxicity test for volumes between 10 and 100 tonnes per year (laid down in Annex VIII) will be also reviewed after 12 years.&#160;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>REACH (Registro, Evaluaci\u00f3n y Autorizaci\u00f3n de Productos Qu\u00edmicos) entr\u00f3 en vigor el 1 de junio de 2007. El nuevo reglamento tiene como objetivo mejorar la\u2026<\/p>","protected":false},"author":110,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[489],"tags":[],"class_list":["post-12783","post","type-post","status-publish","format-standard","hentry","category-industry-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>European Commission&#039;s New Chemical Strategy (REACH) - AgriBusiness Global<\/title>\n<meta name=\"description\" content=\"REACH (Registration, Evaluation, and Authorization of Chemicals) came into force June 1, 2007. 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