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PRODUCT MARKETING AND SALES

EFMA PRODUCT STEWARDSHIP FOR FERTILIZERS

Version 1.5: 01-08-2009

3.1.5 PRODUCT MARKETING AND SALES

INTRODUCTION

 

The Marketing and Sales department of a company has an important role in the Product Stewardship program. It is there where the closest contacts are with the customers. The sales and marketing people can be considered as company's real "Product Stewards" and should be trained accordingly to be able to provide assistance to customers on product related issues. Essential issues are:

  • The identification of risks from the intended use and foreseeable misuse of fertilizers (chapter 3.1.5.3.)
  • The provision of information to and working in partnership with customers (chapter 3.1.5.4.)
  • The handling of product safety complaints, product recall and incidents (chapter 3.1.5.5.).
  • The insurance that customer and regulatory requirements and product quality are met (chapter 3.1.5.6.).

 


 

LEGAL REQUIREMENTS


 

Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances. Official Journal of the European Communities 196, 16.8.1967, p. 1.

Council Directive 79/831/EEC of 18 September 1979 amending for the sixth time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances, Official Journal of the European Communities L 259, 15.10.1979, p. 10.

Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labeling of dangerous preparations, Official Journal of the European Communities L 187, 16.7.1988, p. 14.

Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EEC
Official Journal L 076 , 22/03/1991 P. 0035 - 0041

Council Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances, Official Journal of the European Communities L 154, 5.6.1992, p. 1.

Commission Directive 93/112/EC of 10 December 1993 amending Commission Directive 91/155/EEC defining and laying down detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Council Directive 88/379/EEC. OJ No L314 p.38, 1993/12/16

Commission Regulation (EC) No 1179/94 of 25 May 1994 concerning the first list of priority substances as foreseen under Council Regulation (EEC)No 793/93 Official journal NO. L 131 26/05/1994 P. 0003 - 0004

Council Directive 94/33/EC of 22 June 1994. On the protection of young people at work. OJ.L216 p12-20; 20-08-1994.

European Parliament and Council Directive 94/60/EC amending for the 14th time Directive 76/769/EEC on the approximation of the laws ,regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain substances and preparations. OJ L365 p1-9 of 31-12-1994,

Commission Regulation (EC) No 2268/95 of 27 September 1995 concerning the second list of priority substances as foreseen under Council Regulation (EEC) No 793/93 Official journal NO. L 231 , 28/09/1995 P. 0018 - 0019

Directive 96/56/EC of the European Parliament and the Council of 3 September 1996 amending Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances. Official Journal of the European Communities L 236, 18.9.1996, p. 35.

Commission Regulation (EC) No 143/97 of 27 January 1997 concerning the third list of priority substances as foreseen under Council Regulation (EEC) No 793/93 Official journal NO. L 025 , 28/01/1997 P. 0013 - 0014

Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391 (EEC). OJ no L131/11 5.5.98

Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws , regulations and administrative provisions of the Member States relating to the classification, packaging and labeling of dangerous preparations. OJ L200 p1 30-07-1999

Commission regulation EC 2364/2000 of 25 October 2000 concerning the fourth list of priority substances as foreseen under Council regulation EEC/793/93. OJ L273 26.10.2002 p5.

Commission Directive 2001/58/EC amending for the second time Directive 91/155/EEC defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of article 14 of the European Parliament and Council Directive 1999/45/EC and relating to dangerous substances in implementation of article 27 of Council Directive 67/548/EEC (safety data sheets) OJ L21 2/24 . 7-8-2001.

Commission Directive 2001/60/EC of 7 August 2001 adapting to technical progress Directive 1999/45/EC of the European Parliament and of the Council concerning the approximation of the laws, regulations and administrative provisions of the
Member States relating to the classification, packaging and labeling of dangerous preparations. OJ.L226 p5 22-08-2001

Regulation 2003/2003/EC of the European Parliament and of the Council of 13 October 2003 relating to fertilisers.OJ304/1 20-11-2003

Commission Regulation (EC) No 642/2005 of 27 April 2005 imposing testing and information requirements on the importers or manufacturers of certain priority substances in accordance with Council Regulation (EEC) No 793.93 on the evaluation and control of the risks of existing substances. OJ L 107 of 28-04-2005 p14 -16

Commission Directive 2006/8/EC of 23 January 2006 amending, for the purposes of their adaptation to technical progress, Annexes II, III and V to Directive 1999/45/EC of the European Parliament and of the Council concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (1)OJ 19 P. 12. 14-01-2006

Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending .Directive 67/548/EEC and Regulation (EC) No 1907/2006. Accompanying document to the regulation: Impact Assessment . Brussels , 27.6.2007.

Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006. Accompanying document to the regulation: Summary of the Impact Assessment . Brussels , 27.6.2007

Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006. Volume 1.Brussels, 27.6.2007. COM(2007) 355 final. 2007/0121 (COD)

Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006. Volume II (Annex I) Brussels, 27.6.2007. COM(2007) 355 final. 2007/0121 (COD)

Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006. Volume III - Annexes II to VII. Brussels, 27.6.2007. COM(2007) 355 final. 2007/0121 (COD)

Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006. Volume IIIa - Annexes VI, Table 3.1 . Brussels , 27.6.2007. COM(2007) 355 final. 2007/0121 (COD)

Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006. Volume IIIb - Annex VI, Table 3.2 . Brussels, 27.6.2007. COM(2007) 355 final. 2007/0121 (COD)

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Official Journal of the European Union L396, 30-12-2006 p. 1-850

Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in order to adapt it to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency.Official Journal of the European Union L396, 30-12-2006 p. 850-856.

as amended:

Corrigendum to Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in order to adapt it to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (  OJ L 396, 30.12.2006) . OJ. L 136 Volume 50. 29 May 2007 page 3-281

Corrigendum to Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in order to adapt it to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (  OJ L 396, 30.12.2006). OJ. L 136 Volume 50. 29 May 2007 page 281

Commission Regulation (EC) No 987/2008 of 8 October 2008 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes IV and V. OJ 268 page 14 dd 09-102008.

Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (  OJ L 396, 30.12.2006, p. 1; corrected by  OJ L 136, 29.5.2007, p. 3) OJ L36 5.2.2009 page 84

Commission Regulation (EC) No 134/2009 of 16 February 2009 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XI OJ L46 17.2.2009 page 3

Commission Regulation (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII OJ L164 page 5

Commission Directive 2008/58/EC of 21 August 2008 amending, for the purpose of its adaptation to technical progress, for the 30th time, Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances OJ L246 page 1 dd 15-09-2008.

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. OJ L353 page 1 dd 31 December 2008

Commission Directive 2009/2/EC of 15 January 2009 amending, for the purpose of its adaptation to technical progress, for the 31st time, Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances OJ L11 dd 16-01-2009

Communication from the Commission pursuant to Article 67(3) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) .OJ C130 9 June 2009.

Commission Regulation (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII. OJ 164 page 9 . 26-6-2009.

REACH Fees and charges to be paid to the Agency can be found in:

Commission Regulation (EC) No 340/2008 of 16 April 2008 on the fees and charges payable to the European Chemical Agency persuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). OJ L 107, 17 April 2008 p6.

Test methods in REACH

Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods perusant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). OJ L142 dd 31 May 2008.

 

Restriction of marketing and use

Decision No 1348/2008/EC of the European Parliament and of the Council of 16 December 2008 amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of 2-(2-methoxyethoxy)ethanol, 2-(2-butoxyethoxy)ethanol, methylenediphenyl diisocyanate, cyclohexane and ammonium nitrate. OJ L348/108 dd 24-12-2008

 

Commission Regulation (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII. OJ 164 page 9 . 26-6-2009.

 

 


 

EFMA REQUIREMENTS

 

 

Guidance for the preparation of safety data sheets for fertilzier material

 

 

 

 


 

EFMA IMPLEMENTATION

 

3.1.5.1 CLASSIFY AND LABEL PRODUCTS FOR SUPPLY.

 

EC Fertilizer legislation

Most fertilizers are not classified as dangerous and do not fall under the requirements for classification, packaging and labeling for supply as outlined in the Directives on Dangerous Substances and Dangerous Preparations.
For fertilizers designated as EC Fertilizers, meaning listed in Annex 1 of Regulation 2003/2003/EC and complying with the conditions laid down by said Directive and annexes I to III, the labeling and packaging requirements are given in the articles 7,9,10 and 12.

Regulation 2003/2003/EC of the European Parliament and of the Council of 13 October 2003 relating to fertilisers.OJ304/1 20-11-2003

Commission Regulation (EC) No 1107/2008 of 7 November 2008 amending Regulation (EC) No 2003/2003 of the European Parliament and of the Council relating to fertilisers for the purposes of adapting Annexes I and IV thereto to technical progress OJ L299 dd 8 November, 2008.

 

 

The packing and labeling information should be available in the language of the country of destination (article 11).

Consult also UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS), 2005. ISBN 92-1-116927-5. which includes harmonized hazard communication elements, including requirements for labelling and safety data sheets.

 

 

 

The Directives on Dangerous Substances and Dangerous Preparations.


In the 1960s the national provisions of the six Member States on chemicals differed widely and thus hindered Community trade. In addition, it was recognized that there was a need to ensure the protection of public health, in particular the health of workers handling dangerous substances.

This resulted in the adoption of Directive 67/548/EEC (the Dangerous Substance Directive) in 1967 which sets out harmonized community rules for classification, packaging and labeling of dangerous chemical substances and Directive 88/379/EEC (the Dangerous Preparations Directive) which extends the rules to dangerous preparations.

Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances. Official Journal of the European Communities 196, 16.8.1967, p. 1.

Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labeling of dangerous preparations, Official Journal of the European Communities L 187, 16.7.1988, p. 14.

The Directive on Dangerous substances

This Directive introduced common provisions on the:

  • classification of dangerous substances, since placing a substance into one or several defined classes of danger characterizes the type and severity of the adverse effects that the substance can cause;
  • packaging of dangerous substances, since adequate packaging protects from the known danger(s) of a substance;
  • labelling of dangerous substances, since the label on the packaging informs about the nature of the danger(s) of the substance inside and about the safety measures to apply during handling and use.
  • Protecting the environment from the dangerous effects of substances

 

 

Currently there are fifteen classes of danger in Directive 67/548/EEC, such as "explosive", "very toxic", "carcinogenic" or "dangerous for the environment". The Directive also includes a list of substances classified as dangerous in Annex I, danger symbols (such as a scull with crossed bones underneath) in Annex II, standard phrases on the nature of special risks from substances (R-phrases) in Annex III and the wording of safety precaution phrases (S-phrases) relating to the handling and use of dangerous substances in Annex IV. Annex V contains testing methods to determine the dangerous properties of substances, Annex VI provides detailed criteria on the proper choice of the class of danger and on how to assign the danger symbols, R- and S-phrases to a tested substance. Annexes VII and VIII do not relate to the classification or labeling of substances, but to the notification of "new" substances. Annex IX includes provisions on child-proof fastenings and tactile warning devices as special packaging and labeling elements.

 

The Directive is permanently updated to take account of the scientific and technical progress in the field of dangerous substances. Until today it has been amended 9 times and adapted to technical progress 30 times.

 

 

 

 

In June 2007 The commission has issued an amendment of the Directives 67/548 aligned with REACH (see chapter 3.1.5.3.) and GHS.

 

Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending .Directive 67/548/EEC and Regulation (EC) No 1907/2006. Accompanying document to the regulation: Impact Assessment . Brussels , 27.6.2007.

Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006. Accompanying document to the regulation: Summary of the Impact Assessment . Brussels , 27.6.2007

Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006. Volume 1.Brussels, 27.6.2007. COM(2007) 355 final. 2007/0121 (COD)

Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006. Volume II (Annex I) Brussels, 27.6.2007. COM(2007) 355 final. 2007/0121 (COD)

Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006. Volume III - Annexes II to VII. Brussels, 27.6.2007. COM(2007) 355 final. 2007/0121 (COD)

Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006. Volume IIIa - Annexes VI, Table 3.1 . Brussels , 27.6.2007. COM(2007) 355 final. 2007/0121 (COD)

Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006. Volume IIIb - Annex VI, Table 3.2 . Brussels, 27.6.2007. COM(2007) 355 final. 2007/0121 (COD)

See for full list of directives, annexes and amendments in References (Classification , Labelling and Packaging).

 

 

The Classification, labelling and packaging directive 67/548EEC for substances and the one on mixtures 1999/45/EC have benn merged and adapted to the Global Harmonized System. The two named Directives have been repealed.

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. OJ L353 page 1 dd 31 December 2008

The Dangerous Preparations Directive

The European chemicals industry manufactures and uses a large number of different chemical products. 90 to 95 % of all chemicals on the European market are preparations - i.e. mixtures of chemical substances. They include industrial chemicals, such as solvents and coatings; petrochemicals, such as fuels and lubricants; agricultural chemicals such as pesticides; consumer products, such as detergents and disinfectants, and many others. The majority of these chemicals are of low concern for human health or the environment, but a significant proportion has properties which are hazardous to human health and/or the environment

Directive 88/379/EEC (the Dangerous Preparations Directive) extends the rules of the Dangerous Substances Directive to dangerous preparations. This directive has now been replaced by Directive 99/45/EC (see below). This Directive is the responsibility of DG Enterprise.

  • to identify the intrinsic hazards of the chemicals they manufacture or import (i.e. "classify" chemicals according to their dangers - such as flammability, toxicity, carcinogenicity);
  • to label these chemicals according to strict rules (i.e. warnings about the dangers and safety advice)
  • and to package them safely.


In July 1999, Directive 88/379/EEC was amended by Directive 99/45/EC. This new Directive will replace 88/379/EEC from 30 July 2002 for the majority of preparations, and from 30 July 2004 for plant protection products and biocides. 99/45/EC extends the scope of the dangerous preparations directive to include for the first time pesticides and a requirement to classify and label preparations for environmental hazards. It also revises the text of 88/379/EEC to make it easier to use and understand. Directive 2001/60/EC has recently modified Directive 1999/45/EC.

The annexes II, III, and V of Directive 1999/45 have recently be adapted by Directive 2006/8/EC

 

The Consequences for Downstream users on other Community Legislation arising from the Classification and Labelling of Dangerous Substances under Directive 67/548/EEC is summarized in a paper of the European Commission, Directirate General JRC. Institute fro Health and consumer Protection.ECB.

Repealing Directives 67/548 and 1999/45/EC

The Classification, labelling and packaging directive 67/548EEC for substances and the one on mixtures 1999/45/EC have benn merged and adapted to the Global Harmonized System. The two named Directives have been repealed.

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. OJ L353 page 1 dd 31 December 2008

 

 


 

3.1.5.2 DEVELOP AND SUPPLY SAFETY DATA SHEETS AND PRODUCT SAFETY LITERATURE.

 

Safety Data Sheets


Directives 67/548/EEC and 99/45/EC require producers of dangerous chemicals to provide industrial and professional users with detailed health, safety and environmental information and advice about their products in the form of safety data sheets. Directive 91/155/EEC, as amended by Directives 93/112/EEC and 2001/58/EC, as well as the REACH regulation ( see Chemical Policy below) sets out the requirements for the information which should be included in a safety data sheet.

This information given in the SDS should be made available in the language of the country of destination.

This information, not only covering products classified as dangerous but also non-dangerous products and third party products and update of the information should be forwarded to customers. It is also for that reason important that changes in HSE regulations in the countries where products are sold, are monitored.

The main purpose of safety data sheets is to enable employers to determine whether any hazardous chemicals are present in the workplace, and to assess whether there is any risk to the health and safety of workers and/or to the environment arising from their use. Directive 98/24/EC (which is the responsibility of DG Employment) sets out employers' responsibilities in detail.

Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391 (EEC). OJ no L131/11 5.5.98

Commission Directive 93/112/EC of 10 December 1993 amending Commission Directive 91/155/EEC defining and laying down detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Council Directive 88/379/EEC. OJ No L314 p.38, 1993/12/16

Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EEC
Official Journal L 076 , 22/03/1991 P. 0035 - 0041

Commission Directive 2001/58/EC amending for the second time Directive 91/155/EEC defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of article 14 of the European Parliament and Council Directive 1999/45/EC and relating to dangerous substances in implementation of article 27 of Council Directive 67/548/EEC (safety data sheets) OJ L21 2/24 . 7-8-2001.

UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS), 2005. ISBN 92-1-116927-5.

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Official Journal of the European Union L396, 30-12-2006 p. 1-850

as amended

Corrigendum to Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in order to adapt it to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (  OJ L 396, 30.12.2006) . OJ. L 136 Volume 50. 29 May 2007 page 3-281

Corrigendum to Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in order to adapt it to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (  OJ L 396, 30.12.2006). OJ. L 136 Volume 50. 29 May 2007 page 281

Commission Regulation (EC) No 987/2008 of 8 October 2008 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes IV and V. OJ 268 page 14 dd 09-102008.

Commission Regulation (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII. OJ 164 page 9 . 26-6-2009.

Fact sheets and Workplace safety cards

In addition to SDS's, which are obligatory by law for dangerous goods and which are intended for use not only for the workforce but also for customers, some companies use "fact sheets" or "workplace safety cards". These sheets or cards provide the basic SDS hazard information in a clear language and are intended for use by employees.

 

EFMA's Guidance for the Preparation of Safet Data Sheets for Fertilizer Materials (2008)

In 1996 EFMA produced a guidance booklet on the preparation of Safety Data Sheets (SDSs) (Ref. 1) for the benefit of its members. Its purpose was to help the members of EFMA in the preparation of their own SDSs by describing the requirements of various sections in the relevant EC Directives, 67/548/EEC (Ref. 2) (see note below) and 1999/45/EC for preparations (Ref. 3), and by providing agreed versions of model Safety Data Sheets for several fertilizer materials. It was recognised that some of the materials covered were not legally required to have a SDS but they were included on the principle of good responsible care.
The above-mentioned Directives have been superseded by new, far-reaching legislation, Regulation (EC) No 1907/2006, widely known as REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals (Ref. 4). This Regulation now defines SDS requirements and also introduces new requirements. It has, therefore, become necessary to revise the 1996 EFMA guidance with a view to facilitating
compliance with the current REACH legislation. An EFMA Task Force, set up for this purpose, has produced this new guidance. The previous guidance contained model SDSs for fertilizer materials; these are now given in a separate document (to be released later). The provisional list of substances and preparations thus to be covered is given in Appendix 1.

Guidance for the preparation of safety data sheets for fertilzier material

Guidance for the preparation of safety data sheets for fertilzier material

 

 

Safety literature.

Additional literature on safety, health and environment issues can be supplied to the customer. This with the purpose to enhance safety, prevents accidents to happen and prevent damage to health and the environment. Examples are:

In addition individual EFMA member companies have developed many papers and leaflets to achieve this goal.

 

 

 



3.1.5.3 IDENTIFY, CHARACTERIZE AND EVALUATE RISKS USE AND MISUSE OF PRODUCTS.

 

The Existing Substances Regulation

In 1993 the Council adopted Council Regulation (EEC) 793/93 or the Existing Substances Regulation (ESR), thereby introducing a comprehensive framework for the evaluation and control of "existing" chemical substances¹. The Regulation was intended to complement the already existing rules governed by Council Directive 67/548/EEC for "new" chemical substances². An "Existing" chemical substance is in the EU defined as any chemical substance listed in the European INventory of Existing Commercial Substances (EINECS), an inventory containing 100,195 substances. The Regulation 793/93 foresees that the evaluation and control of the risks posed by existing chemicals will be carried out in four steps:

STEP I Data collection;
STEP II Priority setting;
STEP III Risk assessment;
STEP IV Risk reduction.

Step I: Data Collection

The Regulation was initially concerned with the so-called High Production Volume Chemicals (HPVCs). HPVCs are those substances which are covered by the data collection phases I and II of the Regulation, i.e., which have been imported or produced in quantities exceeding 1000 tonnes per year and produced/imported between March 23, 1990 and March 23, 1994. In phase III of the data collection step, companies which produce or import existing substances in quantities between 10 and 1000 tonnes per year (Low Production Volume Substances or LPVCs) were required to submit a reduced data-set by June 4, 1998. All the data have to be submitted in a specific electronic format Harmonized Electronic DataSET (HEDSET) and is managed by the International Uniform ChemicaL Database (IUCLID). Furthermore, all companies which have submitted a data-set in any of the three data collection phases are required to update the information, at least once every three years.

Step II: Priority Setting

Article 8 of the Regulation states that the Commission, in consultation with the Member States, will regularly draw up lists of priority substances which require immediate attention because of their potential effects to man or the environment. The Commission and Member States utilize the information collection during step 1 of the regulation as a basis for selecting priority substances. Since 1994, four such priority lists have been published, the first, second, third and fourth priority lists

Commission Regulation (EC) No 1179/94 of 25 May 1994 concerning the first list of priority substances as foreseen under Council Regulation (EEC)No 793/93 Official journal NO. L 131 26/05/1994 P. 0003 - 0004

Commission Regulation (EC) No 2268/95 of 27 September 1995 concerning the second list of priority substances as foreseen under Council Regulation (EEC) No 793/93 Official journal NO. L 231 , 28/09/1995 P. 0018 - 0019

Commission Regulation (EC) No 143/97 of 27 January 1997 concerning the third list of priority substances as foreseen under Council Regulation (EEC) No 793/93 Official journal NO. L 025 , 28/01/1997 P. 0013 - 0014

Commission regulation (EC) 2364/2000 of 25 October 2000 concerning the fourth list of priority substances as foreseen under Council regulation EEC/793/93. OJ L273 26.10.2002 p5.

Step III: Risk Assessment

Substances on priority lists must undergo an in-depth risk assessment covering the risks posed by the priority chemical to man (covering workers, consumers and man exposed via the environment) and the environment (covering the terrestrial, aquatic and atmospheric eco-systems and accumulation through the food chain). This risk assessment follows the framework set out in Commission Regulation (EC) 1488/94 and implemented in the detailed Technical Guidance Documents (TGD) on Risk Assessment for New and Existing Substances. The first draft of the risk assessment reports are written by the Member States which act as "rapporteurs". The Commission mediates the meetings, which attempt to reach consensus on the conclusions of the risk assessments. After adoption of the risk assessment, three publications are produced:


1. the comprehensive risk assessment report (as a book, on the ECB Web Site and in the International Uniform ChemicaL Database (IUCLID)),
2. a summary thereof (as a EUR report and on the ECB Web Site)
3. a listing of the conclusions in the Official Journal of the European Communities.

Directive EEC 793/93 has been amended by Commission Regulation EC 642/2005. This amendment imposes test information requirements on the importers and manufacturers of certain priority substances as named in the annex of the amendment. Although not directly relevant to our Industry further testing of Cadmium and Cadmium oxide is required.

Commission Regulation (EC) No 642/2005 of 27 April 2005 imposing testing and information requirements on the importers or manufacturers of certain priority substances in accordance with Council Regulation (EEC) No 793.93 on the evaluation and control of the risks of existing substances. OJ L 107 of 28-04-2005 p14 -16

 

 

 

The ICCA HPV Program

The International Council of Chemical Associations (ICCA) HPV Chemicals Initiative ( launched on 3 October 1998) is a voluntary action by chemical companies, primarily in Europe, Japan and North America, to deliver globally harmonized data and initial hazard assessments for some 1,000 High Production Volume (HPV) chemicals by the end of 2004. The information, i.e. a Screening Information Data Set Dossier (SIDS Dossier), a SIDS Initial Assessment Report (SIAR) and a SIDS Initial Assessment Profile (SIAP), will be submitted to the OECD for international agreement as part of its refocused HPV Chemicals Program. The output from the Initiative will provide a sound scientific basis for subsequent global, regional and/or national assessment, voluntary industry action or risk management.
The Fertilizer Institute (TFI, Washington, D.C.) and the European Fertilizer Manufacturers Association (EFMA, Brussels, Belgium) signed a joint agreement to share fertilizer product toxicity testing information by combining results of their respective product toxicity testing programs. Under the agreement, TFI and EFMA generated toxicological data on high production volume fertilizers. TFI began its product testing program in 1999 and the project has been completed in 2003. EFMA began with a program of Harmonized Electronic Data Sets (Hedsets) in 1995.

The information generated as a result of this joint project provides North American and European fertilizer manufacturers with scientific data on the safety of fertilizer products. This data will be summarized according to the Organization for Economic Cooperation and Development's Screening Information Data Set (SIDS) format. The OECD countries have agreed on a set of tests and on types of data that are generally necessary to characterize the behavior and potential hazards of chemicals released into the environment. Today the test results are available and EFMA will procede fulfilling further requirements of the ICCA program.

 

 

 

EU Policy on Chemicals (REACH)

The White Paper final Document 13-02-2001 gives the strategy for a future EU Chemicals Policy.
All existing (declared to be on the market in September 1981) and new substances (i.e. those placed on the market since that date) will be part of the same system: REACH (Registration, Evaluation and Authorizsation of Chemicals).

 

Registration

• For all substances produced or imported in quantities of 1 ton or more per year, manufacturers and importers must prepare a registration dossier to be submitted to the European Chemicals Agency. It is industry¡¯s task to gather and assess the required information (requirements mainly based on volume, comprises data on physicochemical, toxicological and eco-toxicological properties). In addition to these data on the substance, individual identified uses of downstream users throughout the supply chain as well as assessments of the associated risks and safety measures derived from these must be specified. If further testing needs to be undertaken a test plan is required as well.
• For substances with annual volumes of more than 10 tons, the assessment of the safe handling (Chemical Safety Assessment) must be documented in a Chemical Safety Report.

Evaluation

• Dossier evaluation: The Member States authorities can check the compliance of any registration dossier with the requirements of REACH, and examine and endorse the testing proposals provided by the industry.
• Substance evaluation: The Member State authorities are allowed to examine registration dossiers in order to evaluate whether a substance presents a risk to human health or the environment, and to determine the need for possible authorisation or restriction of marketing and use.

Authorisation

• Authorisation will be required for each use of a substance belonging to specific groups, i.e. substances of very high concern - CMRs category 1 and 2 (carcinogenic, mutagenic or toxic to reproduction), PBTs (persistent, bio-accumulative and toxic), vPvBs (very persistent and very bio-accumulative) and other substances identified as causing serious and irreversible effects on humans and the environment.
• Authorisation will be granted for these uses if the manufacturer or importer is able to demonstrate that risks can be adequately controlled. If such evidence cannot be provided, authorisation can only be granted if an analysis shows that the socio-economic advantages of the specific use are predominant.

Restriction

• If a risk is identified as not being adequately controlled, a proposal to restrict marketing and use of a substance can be made by the Commission or a Member State. The decisions on restriction are taken by the Commission in consultation with the Member States.


The new European Chemicals Agency will be established to facilitate the registration tasks (including establishing and maintaining the necessary databases). The Member States still have the responsibility for evaluation and authorisation phases. The final decision on authorisation will be taken by the Commission, in consultation with the Member States.

 

The full text of the regulation can be found in:

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Official Journal of the European Union L396, 30-12-2006 p. 1-850

Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in order to adapt it to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency.Official Journal of the European Union L396, 30-12-2006 p. 850-856.

as amended:

Corrigendum to Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in order to adapt it to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (  OJ L 396, 30.12.2006) . OJ. L 136 Volume 50. 29 May 2007 page 3-281

Corrigendum to Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in order to adapt it to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (  OJ L 396, 30.12.2006). OJ. L 136 Volume 50. 29 May 2007 page 281

Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (  OJ L 396, 30.12.2006, p. 1) (Corrected version in  OJ L 136, 29.5.2007, p. 3) OJ L141 pagfe 22 31-05-2008

Commission Regulation (EC) No 987/2008 of 8 October 2008 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes IV and V. OJ 268 page 14 dd 09-102008.

Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (  OJ L 396, 30.12.2006, p. 1; corrected by  OJ L 136, 29.5.2007, p. 3) OJ L36 5.2.2009 page 84

Commission Regulation (EC) No 134/2009 of 16 February 2009 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XI OJ L46 17.2.2009 page 3

Commission Regulation (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII OJ L164 page 5

Communication from the Commission pursuant to Article 67(3) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) .OJ C130 9 June 2009.

Commission Regulation (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII. OJ 164 page 9 . 26-6-2009.

Fees and charges to be paid to the Agency can be found in:

Commission Regulation (EC) No 340/2008 of 16 April 2008 on the fees and charges payable to the European Chemical Agency persuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). OJ L 107, 17 April 2008 p6.

 

Test methods in REACH

Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods perusant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). OJ L142 dd 31 May 2008.

 

REACH Implementation Projects (RIPs)

 

Reach Implementation Projects are projects launched by the Commission to assist the industry and the authorities to implement REACH.

The folllowing Guidance documents have been issued by the European Chemical Bureau (ECHA):

Guidance for the preparation of Annex XV dossier for restrictions
Guidance for the preparation of an Annex XV dossier on the identification of Substances of very high concern Guidance for the preparation of an Annex XV dossier on Harmonised Classification and Labelling Guidance for intermediates Guidance on data sharing
Guidance for the preparation of an Annex XV dossier for restrictions Guidance for the preparation of an Annex XV dossier on the identification of substances of very high concern Guidance for the preparation of an Annex XV dossier on Harmonised Classification and Labelling

Guidance for intermediates

Update February 2008

Guidance on data sharing
IUCLID 5 Guidance and Support Guidance on registration Guidance on Dossier and Substance Evaluation Guidance for identification and naming of substances under REACH
IUCLID 5 Guidance and support

Guidance on registration

update April 2008

Guidance on Dossier and Substance Evaluation Guidance for identification and naming of substances under REACH

Guidance for downstream users

update January 2008

Click on icon to follow the link to the documents

 

R.I.P. 3.2. concerns guidance on the Chemical Safety Reports. EFMA participates in R.I.P. 3.2.2. regarding the Guidance on Risk Assessment (RA) and Exposure Scenarios (ES).

The Guidance on Information Requirements and Chemical Safety Assessment R.I.P. 3.2

Part A - Introduction to the Guidance Document
Part B - Hazard Assessment
Part C - PBT Assessment
Part D - Exposure Scenario Building
Part E - Risk Characterisation
Part F - Chemicals Safety Report
Part G - Extension of SDS
Information requirements
Information gathering
Evaluation of available information
Adaptation of Information requirements
QSARs and grouping of chemicals
Endpoint specific guidance 7a
Endpoint specific guidance 7b
Endpoint specific guidance 7c
Characterisation of dose [concentration] - response for human health
Physico-chemical hazards
Characterisation of dose [concentration] - response for environment
PBT Assessment
Use descriptor system
Risk management measures and operational conditions
Occupational exposure estimation
Consumer exposure estimation
Environmental exposure estimation
Estimation of exposure from articles
Estimation of exposure from waste life
Uncertainty analysis
Table of terms

How to submit a valid dossier to ECHA and complete the dossier header (Release 1

Data Submission Manual 4 25-06-2008

Submission form nr. 2

 

 

 

 

 

 

 

 

 

 

Restriction of marketing and use

As a resutl of the discussions in "Precursor" Workgroup (DG Justice) measures were taken to not placing on the market after 27 June 2010 as a substance, or in
preparations that contain 16 % or more by mass of nitrogen in relation to ammonium nitrate except for supply to named professional users.

Decision No 1348/2008/EC of the European Parliament and of the Council of 16 December 2008 amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of 2-(2-
methoxyethoxy)ethanol, 2-(2-butoxyethoxy)ethanol, methylenediphenyl diisocyanate, cyclohexane and ammonium nitrate. OJ L348/108 dd 24-12-2008

Commission Regulation (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII. OJ 164 page 9 . 26-6-2009.

 

 


 

3.1.5.4 PROVIDE INFORMATION TO, AND WORK IN PARTNERSHIP WITH, CUSTOMERS.

 

In order to prevent that adverse effects on Safety, Health and the Environment occur, SHE information is given to distributors and farmers and to general public (see also chapter 6.4).

Depending on the target group the following SHE information can be provided:


The sales staff should be trained in agronomic aspects and correct application of product, handling and storage of products for product quality and SHE and handling complaints and inquiries.

Support to customer's premises or operations can be organized to ensure:

  • Correct handling and storage of products for product quality purposes
  • Correct handling for SHE
  • Correct application of fertilizers
  • Correct handling of non-conforming material
  • Measures of security

The company can offer specific training of customers on the correct storage and handling of products.

 

 



3.1.5.5 HANDLE PRODUCT SAFETY COMPLAINTS, PRODUCT RECALL AND INCIDENTS.

 

 

Inquiries and complaints


A procedure for dealing with inquiries and complaints should be in place covering the following aspects:

  • Feedback to the complaining party
  • Feedback to organization for complaint handling
  • Recordkeeping


Product recall


A system for product recall should be in place.

Emergencies


An assessment for the potential impact and response should be in place covering:

  • Incidents at customers' locations
  • Incidents at farmers' location
  • Exposure to people and animals
  • Environmental threats
  • Tthreats and other security issues

A procedure should be in place for handling of emergency calls at all times and for reporting to senior management of product related emergencies and incidents at customer's premises. The information on all product related emergencies and incidents at customer's and farmers' locations should be available for central retrieval.

 

 





3.1.5.6 CONFORM WITH CUSTOMERS AND REGULATORY REQUIREMENTS AND PRODUCT QUALITY

 

All fertilizer products in the European market must conform to specific quality requirements set by the authorities. These are described in the Regulation 2003/2003/EC of the European Parliament and of the Council of 13 October 2003 relating to fertilisers.OJ304/1 20-11-2003. In addition, customers will set requirements to their purchases with relation to product nutrient contents and product quality characteristics. Companies will have quality assurance procedures to document the required characteristics, and carry out the necessary sampling and laboratory analyses accordingly. In order not to detoriate the product quality along the distribution chain, the operations must include best practices handling routines.

 

 

 

3.1.5.7. SECURITY

 

In response to the increased concern related to terrorism and misuse of fertilizers, EFMA recognises the need for addressing security in production, storage, transportation and sales of fertilizers. Hence, EFMA has updated its Product Stewardship program to cover this important topic in more depth and in accordance with recently expressed demands by the authorities. EFMA's recommendations for security measures are not made available in this description of EFMA's Product Stewardship program. It is available for EFMA members only and is part of the EFMA auditing system for evaluating the adherence to the recommendations amongst the members.

 

EFMA's recommendations for security measures.

Members Only

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EFMA's security measures

 

 

 


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